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CUTTING-EDGE ADVANCEMENTS CLINICAL DIAGNOSIS Drug Therapy TRACKING SOURCE OF INFECTION AFTER BLEPHAROPLASTY March 1, 2017 VOL. 42, NO. 4 SURGERY DRUG THERAPY Eye drop may reform wet AMD treatment Phase I/II trial with next-generation suspension formulation slated for second half of 2017 INFECTIONS AFTER blepharoplasty are uncommon with or without the use of an antibiotic ointment. However, if infections occur, be suspicious of community-acquired methicillin-resistant Staphylococcus aureus, said Mark A. Alford, MD. He made those conclusions based on his prospective, cohort, observational study on the topic. When antibiotic ointments are used, the infection rate after blepharoplasty is extremely low, at only 0.2%. VEGF-A Topical Eye Drop (PAN-90806) Endothelial Cell VEGFR2 Novel Small-Molecule VEGFR2 Tyrosine Kinase Inhibitor Receptor Activation > Nanomolar potency, selective inhibitor of VEGFR2 (IC50=1.27nM) > Topical efficacy demonstrated in validated animal models of ocular angiogenesis and CNV GO AHEAD, LOOK IINSIDE P P P P Receptor eceptor kinase > Attractive physical-chemical properties for topical delivery ( See story on page 22 : Infection rate ) (Image courtesy of Scott Cousins, MD) Special Report WAVEFRONT ADD-ON ENHANCES MIXED ASTIGMATISM PATIENTS WITH mixed astigmatism can be challenging to treat with LASIK. The recent FDA approval of a new indication for wavefront-guided technology could make treatment for this patient segment a little easier. Used in tandem with an excimer laser system, the wavefront technology provides surgeons with detailed information for precise and individualized treatment. The approval with mixed astigmatism helps reach another potential group of patients, said Robert K. Maloney, MD. ( See story on page 14 : Astigmatism ) OphthalmologyTimes.com VASCULAR PERMEABILITY ANGIOGENESIS By Lynda Charters; Reviewed by Scott Cousins, MD A NOVEL VASCULAR ENDOTHELIAL growth factor receptor 2 (VEGFR2) inhibitor delivered as a topical eye drop (PAN-90806, PanOptica) might just revolutionize treatment of the neovascular form of age-related macular degeneration (AMD) by making intravitreal injections of anti-VEGF drugs a thing of the past for certain patients. One major benefit for this topical therapy is that the risks associated with intravitreal anti-VEGF injections to treat AMD would be eliminated. The drug was found to improve certain biologic outcomes for patients with wet AMD who presented with milder lesions characterized by thinner subfield thickness and small area. IS IT TALENT OR SKILL? This molecule is a selective inhibitor of VEGFR2 (50% inhibitory concentration, 1.27 nM), said Scott Cousins, MD, the Robert Machemer Professor of Ophthalmology and Immunology, vice chairman for research, and director of the Duke Center for Macular Diseases, Duke Eye Center, Durham, NC. In a phase I/II dose-ranging trial for neovascular AMD, Dr. Cousins and colleagues sought to assess the safety and tolerability of the drug, establish a topical maximal tolerated dose, and look for signals of biologic activity. In the stage 1 monotherapy study phase, 40 patients were treated with one of five doses of PAN90806 tested ranging from 1 to 4 mg/ml once to twice daily for 8 weeks. In the stage 2 maintenance study phase, in which ( Continues on page 24 : Topical ) Determining which asset is more important for ophthalmologists PAGE 4 CHECK IIT OUT at Xiidra-ECP.com Marks designated ®CPFvCTGQYPGFD[5JKTGQTCPCHƂNKCVGFEQORCP[ �5JKTG75+PE.GZKPIVQP/#5 MARCH 1, 2017 :: Ophthalmology Times contents IMPORTANT PRODUCT INFORMATION FOR THE ACRYSOF® IQ RESTOR® FAMILY OF IOLs CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician. INDICATIONS: The AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lens (IOL) is intended for primary implantation for the visual correction of aphakia secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag. WARNINGS/PRECAUTIONS: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. Physicians should target emmetropia, and ensure that IOL centration is achieved. Care should be taken to remove viscoelastic from the eye at the close of surgery. Some patients may experience visual disturbances and/or discomfort due to multifocality, especially under dim light conditions. As with other multifocal IOLs, visual symptoms may be significant enough that the patient will request explant of the multifocal IOL. Spectacle independence rates vary with all multifocal IOLs; as such, some patients may need glasses when reading small print or looking at small objects. Clinical studies with the AcrySof® ReSTOR® lens indicated that posterior capsule opacification (PCO), when present, developed earlier into clinically significant PCO. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon for this product informing them of possible risks and benefits associated with the AcrySof® IQ ReSTOR® IOLs. Studies have shown that color vision discrimination is not adversely affected in individuals with the AcrySof® Natural IOL and normal color vision. The effect on vision of the AcrySof® Natural IOL in subjects with hereditary color vision defects and acquired color vision defects secondary to ocular disease (e.g., glaucoma, diabetic retinopathy, chronic uveitis, and other retinal or optic nerve diseases) has not been studied. Do not resterilize; do not store over 45° C; use only sterile irrigating solutions such as BSS® or BSS PLUS® Sterile Intraocular Irrigating Solutions. ATTENTION: Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions. 26 14 22 Clinical Diagnosis Special Report 12 DIAGNOSING, MANAGING VIRAL OCULAR INFECTIONS 15 NEW TECHNIQUE FOR LASIK FLAP VISUALIZATION Viral strain, latency site, host immunity may be contributing factors to different virus manifestations of same microbe Circular polarization technique highlights corneal structures which otherwise remain difficult to visualize In This Issue 4 EDITORIAL What’s Trending See what the ophthalmic community is reading on OphthalmologyTimes.com 1 Apps for busy ophthalmologists OphthalmologyTimes.com/OphthalmicApps 2 What to do when the rhexis won’t tear 27 MARKETPLACE Digital App Introducing the Ophthalmology Times app for iPad and iPhone. Download it for free today at OphthalmologyTimes. com/OTapp OphthalmologyTimes.com/RhexisTear 3 Why Acanthamoeba diagnosis is often challenging OphthalmologyTimes.com/ AcanthamoebaDiagnosis 4 Best place to retire: Florida, Costa Rica, or Mars? OphthalmologyTimes.com/RetireOnMars © 2016 Novartis 10/16 US-RES-16-E-4014 6 FOCAL POINTS Find us on eReport Sign up for Ophthalmology Times’ weekly eReport at Ophthalmologytimes. com/eReport 3 4 MARCH 1, 2017 :: Ophthalmology Times editorial MARCH 1, 2017 ◾ VOL. 42, NO. 4 CONTENT Is it talent or skill? Determining which asset is more important for ophthalmologists By Peter J. McDonnell, MD director of the Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, and chief medical editor of Ophthalmology Times. He can be reached at 727 Maumenee Building 600 N. Wolfe St. Baltimore, MD 21287-9278 Phone: 443/287-1511 Fax: 443/287-1514 E-mail: [email protected] “Talent wins games, but teamwork and intelligence win championships.” —Michael Jordan MY COLLEAGUE, Bert, an ophthalmologist and loyal Ophthalmology Times reader, shared with me a best-selling book entitled: “Talent is Overrated: What Really Separates World-Class Performers From Everybody Else.” The author, Geoff Colvin, argues that our successes are more the product of hard work and less a function of our DNA. There is an ongoing controversy surrounding the importance of talent for athletes, musicians, physicians, and other professionals. Some argue talented people are better at learning certain things (developing skills). Others maintain that use of the term “talent” is really a cop-out, an excuse for those who don’t want to devote the time and effort required to master the skills we see others exhibiting. To this way of thinking, a decision not to do something (“I just don’t have his/her talent”) is likely flawed because we are thinking a talent is just a skill in disguise. WHICH IS IT? What is the truth when it comes to ophthalmology? To address, I assembled a group of ophthalmologists of varying ages, from different countries and ethnic backgrounds, and with different career paths (academia, private practice). What they all had in common is that, by all appearances, they are extremely successful and admired in their communities. These ophthalmologists agreed that if something can be learned, it is a skill. If something is innate, they agreed to call it a talent. They also agreed on the spelling of “skill” and “talent,” but on little else. “How much of your success in your profession is due to talent and how much to skill?” I asked the group. This was a forced-choice question—talent or skill—ignoring other variables, such as luck. The answers varied tremendously and no consensus emerged: > “Eighty percent is due to talent,” answered one colleague. “I was born with a maniacal attention to detail, and this allows me to rapidly recognize if something in the clinic or operating room is not going perfectly and make a correction so as to avoid a serious problem developing.” > “Thirty percent is talent,” said the next respondent. “My skills are the result of many years of hard work, study, and excellent training.” > “Fifty percent is talent and 50% is skill,” said another colleague. “I have the talent but I was taught how to use and take advantage of it. In particular, I was taught how to talk to patients.” One respondent made a comment that seemed to resonate with most of the others: “I can recognize talent because I teach young ophthalmology residents and fellows. Some of them learn more readily because they have a gift or talent in an area, while some of them have a better work ethic. Some go faster than others, but they all get there eventually: whether they become superlative is a function of effort.” They did agree that while having talent is wonderful, it is not sufficient. They considered themselves and their fellow ophthalmologists, who, in their opinions were very successful, to have unusually strong work ethics. Another ophthalmologist offered this perspective that seemed to enjoy wide support: “Our field is disproportionately populated by people willing to spend the time to develop our skills to the highest level and we are inspired to do so by others. We are spurred on by failures because our own standards are so high.” Q Chief Medical Editor Peter J. McDonnell, MD Group Content Director Mark L. 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Coleman, MD Joan Miller, MD Jules Stein Eye Institute, UCLA Los Angeles, CA Massachusetts Eye & Ear Infirmary Harvard University Boston, MA Ernest W. Kornmehl, MD Harvard & Tufts Universities Boston, MA Associate Medical Editors Robert K. Maloney, MD Dimitri Azar, MD Los Angeles, CA University of Illinois, Chicago Chicago, IL Ashley Behrens, MD Wilmer Eye Institute, Johns Hopkins University Baltimore, MD Elizabeth A. Davis, MD University of Utah Salt Lake City, UT Ophthalmology Times’ vision is to be the leading content resource for ophthalmologists. Robert Osher, MD Through its multifaceted content channels, Ophthalmology Times will assist physicians with the tools and knowledge necessary to provide advanced quality patient care in the global world of medicine. Kuldev Singh, MD Jonathan H. Talamo, MD Stanford University Stanford, CA Harvard University Boston, MA Joshua D. 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Randall Olson, MD University of Cincinnati Cincinnati, OH Anterior Segment/Cataract Cornea/External Disease Ophthalmology Times Mission Statement Uveitis Practice Management Joseph C. Noreika, MD Medina, OH Emmett T. Cunningham Jr., MD, PhD Stanford University Stanford, CA Frank Weinstock, MD Chief Medical EditorsEmeritus Boca Raton, FL Refractive Surgery Digital SLR Camera Upgrades Universal Smart Phone Adaptor for Slit Lamp Imaging Bascom Palmer Eye Institute, University of Miami Jack M. Dodick, MD Miami, FL William Culbertson, MD New York University School of Medicine Bascom Palmer Eye Institute, University of Miami New York, NY (1976–1996) Robert Ritch, MD Miami, FL New York Eye & Ear Infirmary New York, NY Peter S. Hersh, MD Joel Schuman, MD University of Medicine & Dentistry of New Jersey Newark, NJ NYU Langone Medical Center New York, NY David R. Guyer, MD New York, NY (1996–2004) Ophthalmology Times Industry Council John Bee Bob Gibson Aziz Mottiwala Rhein Medical Inc. President and CEO Topcon Medical Systems Inc. Vice President of Marketing Allergan Vice President of Marketing, U.S. Eye Care Alastair Douglas Andrew Jones Alcon Laboratories Inc. Director of U.S. Commercial Support Reichert Technologies Director of Global Sales and Marketing Ikegami HD Video for Surgical Microscopes & Slit Lamps How to Contact Ophthalmology Times Editorial Subscription Services Advertising 24950 Country Club Blvd., Toll-Free: 888/527-7008 or 218/740-6477 Suite 200 North Olmsted, OH 44070-5351 FAX: 218/740-6417 440/826-2800 FAX: 440/756-5227 485 Route 1 South Building F, Suite 210, Iselin, NJ 08830-3009 732/596-0276 FAX: 732/596-0003 Production 131 W. First St. Duluth, MN 55802-2065 800/346-0085 FAX: 218/740-7223, 218/740-6576 Made in USA TTI Medical TƌĂŶƐĂŵĞƌŝĐĂŶ TĞĐŚŶŽůŽŐŝĞs InternaƟŽŶĂl Phone: +1-925-553-7828 email: info@ƫŵĞĚŝĐĂů.ĐŽm www.ƫŵĞĚŝĐĂů Đom 6 MARCH 1, 2017 :: Ophthalmology Times focal points Work of eye bank network shows far-reaching impact Organization, physicians work together from procurement to placement of corneal tissue Eye on Research By Erin Murphy vents happen fast in eye banking— corneal tissue is donated, procured, evaluated, processed, preserved, matched, delivered, and transplanted in as little as a day. Into this process go years of work—not only by the surgeons carrying out sight-saving procedures, but also by eye banking leaders who have built a reliable, efficient system to speed corneal tissue from procurement to placement all over the world, every day. The largest of these eye bank networks is the non-profit, Vision Share, which offers eye tissue, eye banking expertise, education, and industry leadership in the United States and abroad. Today, the organization is entering a time of industry-driven expansion. A new headquarters in downtown Chicago is surrounded by world-class, health-care institutions and universities. A growing staff is joined by its new president and chief executive officer, Philip Waitzman, MBA, MPH, MA, who is already working to expand capabilities aimed at making a “positive, meaningful impact in the ophthalmic community and focused on maintaining the integrity of the industry.” During this period of change, its leaders continue to view the organization’s role as a world leader in eye banking. It is an honor, they say, to perform the behind-the-scenes work needed to make that one-day transition from donor to recipient, from blindness to sight. They con- E tinue to build on the organization’s 20-year commitment to eye banking through a set of carefully considered goals. BUILDING A NETWORK Eye banks can accomplish more together than alone. The organization has worked to build the largest network of non-profit eye banks in the world, with 13 members and 20 eye banks in the United States and a vast network of providers at home and abroad. Member organizations provide the expertise in recovery and preparation, while the organization offers an easyto-use, yet sophisticated distribution network. Together, the network and its members are able to meet local, national, and international eye tissue needs. In fact, the organization’s eye banks provide more than one-half the supply of donor corneas in the United States with more than 20,000 placements in 2016 alone. It has worked to build the largest network of non-profit eye banks in the world, with 13 members and 20 eye banks in the United States and a vast network of providers at home and abroad. E X PA N DI NG GL OB A L LY Because the United States has more donor tissue than it requires for transplant procedures, the organization’s network reaches beyond borders to coordinate with domestic and international eye banks and surgeons to distribute donor corneas around the world. The non-profit’s efforts to raise transplant awareness and ophthalmic clinical competencies through collaboration with industry partners extend globally as well. For the patients of Prof. Mohammed Belmekki, ophthalmologist at the Cheikh Zaid Hospital, Rabat, Morocco, the organization’s international outreach has made a marked improvement. “In the past, my patients who needed corneal transplant surgery faced long waits of 6 to 12 months as we worked to obtain the necessary tissue,” Dr. Belmekki said. “Since I began working with Vision Share last August, we have reduced that wait to under 4 months, and we have fewer patients on the waiting list,” he said. “We hope to reach a 1-month delay.” FOR MORE FROM OPHTHALMOLOGY TIMES Join the discussion at Facebook.com/ OphthalmologyTimes Follow us @OphthTimes In 2016, Vision Share eye banks provided more than half the supply of U.S. donor corneas with over See more images at Instagram.com/ OphthalmologyTimes 20,000 PLACEMENTS Find us on all of these platforms Listen to full interviews at Soundcloud.com/ OphthalmologyTimes Watch more surgical procedures and pearls at YouTube.com/ OphthalmologyTimes 8 MARCH 1, 2017 :: Ophthalmology Times surgery Keratoprosthesis implant potentially helpful, but tricky Important for physicians to counsel patients, manage expectations for successful surgery By Laird Harrison; Reviewed by Donald J. D’Amico, MD Successful implantation begins with a carepermanent keratoprosthesis (KPro) can help restore the vi- ful history and detailed exam with ultrasound, sion of patients with severe cor- and it is helpful to look at the optic nerve to neal disease, but clinicians must see whether it is cupped out, Dr. D’Amico said. watch for complications, said A widefield camera provides a good view, he added, and should be used routinely to examDonald J. D’Amico, MD. The artificial cornea “is in- ine the fundus. In patients with uncertain visual potential, creasingly used in ophthalmology and if you haven’t seen patients with [this device], you Dr. D’Amico and his team will often perform a soon will,” said Dr. D’Amico, professor of oph- brief exploratory surgery and endoscopy in a thalmology and chairman, Weill Cornell Medi- separate sitting to see if it is worth going forward with the synthetic cornea subsequently. cal College, New York. If the patient has decided to have the deThe synthetic cornea is typically used in patients whose corneal transplants have failed, vice implanted, it is important to manage the in patients with chemical burns, and in Ste- patient’s expectations. “Counsel patients that they will need convens-Johnson syndrome, he said. “It compares favorably to repeat biologic pen- tact lens and drops lifelong or as long as the etrating keratoplasty in many eyes, even after [device] is in place,” he recommended. At Weill Cornell, Dr. D’Amico and his cola single, failed corneal transplant,” D’Amico leagues prefer to place the artificial cornea in an added. He focused on the Boston KPro (Massachu- aphakic patient rather than in a pseudophakic one. They perform a full pars setts Eye and Ear Infirmary), plana vitrectomy at the time which he referred to as the of implantation, routinely 25Dohlman KPro in deference to The vision of gauge. They enter 4.5 to 7 mm its original designer, Claes H. patients with severe from the center of the device, Dohlman, MD, PhD. corneal disease may and always examine the posbe improved with terior segment carefully while TWO VERSIONS the implantation of the eye is open prior to device There are two types of Boston an artificial cornea. placement. KPro implants. Type 1 consists Donald J. D'Amico, “Any time the eye is open of a plastic front/back plate with MD, provides for a corneal procedure, even a doughnut of donor corneal tissome surgical a straight transplant, just simsue sandwiched between, and a pearls for avoiding ply put light pipe above or into locking ring to hold it together. and managing the vitreous lake and get a view The type 2 Boston KPro—depostoperative of the posterior segment,” Dr. signed for severe, end-stage occomplications in this D’Amico said. “It’s ridiculous ular surface disorders—is simipatient populace. to be struggling for a view on lar to the type 1 device, but rethe first postoperative day when quires a permanent tarsorrhayou had an unroofed eye earphy to be performed through which a small anterior nub of the type 2 model lier that offered a wonderful view.” Dr. D’Amico and his colleagues recently have protrudes. Recent models have featured a titanium back recorded surprising findings after more recent plate intended to enhance biointegration. Some implantations. “Recently, we’ve noted biointegration of the patients do not like the way the titanium looks, so experiments are under way to dye the tita- new devices and we don’t quite know why,” he added. nium a more natural color. A TAKE-HOME A B A. The intraoperative view of a retinal detachment repair in an eye with a permanent keratoprosthesis (KPro). B. Retroprosthetic KPro membrane is opened with a bent needle during vitrectomy. (Images courtesy of Donald J. D'Amico, MD) They are investigating a theory that epithelium growing over the device may help reduce the risk of infection He also advised using anterior segment optical coherence tomography to monitor the wound integrity surrounding the implanted device. COMMON POSTOPER ATIVE COMPLICATIONS In addition to glaucoma and vitreous hemorrhage, some of the most common postoperative complications associated with device implantation include: > Retroprosthetic membrane. The growth of this membrane occurs in about one-half of all device implantations. For this reason, Dr. D’Amico prefers to place the device in an aphakic patients—having to remove a membrane in the presence of an IOL makes a membranectomy that more difficult. An Nd:YAG laser can sometimes open the membrane, but vitrectomy is frequently necessary. Continues on page 11 : Implantation BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION FOR COMPLETE DETAILS, SEE FULL PRESCRIBING INFORMATION. 1 INDICATIONS AND USAGE EYLEA® (aflibercept) Injection is indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR) in Patients with DME. 2 DOSAGE AND ADMINISTRATION 2.1 Important Injection Instructions. For ophthalmic intravitreal injection. EYLEA must only be administered by a qualified physician. 2.2 Neovascular (Wet) Age-Related Macular Degeneration (AMD). The recommended dose for EYLEA is 2 mg (0.05 mL or 50 microliters) administered by intravitreal injection every 4 weeks (monthly) for the first 12 weeks (3 months), followed by 2 mg (0.05 mL) via intravitreal injection once every 8 weeks (2 months). Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 week (monthly) dosing after the "%./0āĂƬ3!!'/Ĩă)+*0$/ĩċ 2.3 Macular Edema Following Retinal Vein Occlusion (RVO). The recommended dose for EYLEA is (0.05 mL or 50 microliters) administered by intravitreal injection once every 4 weeks (monthly). 2.4 Diabetic Macular Edema (DME). The recommended dose for EYLEA is (0.05 mL or 50 microliters) administered by intravitreal injection every 4 weeks (monthly) for the first 5 injections followed by 2 mg (0.05 mL) via intravitreal injection once every 8 weeks (2 months). Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 week (monthly) dosing after the first 20 weeks (5 months). 2.5 Diabetic Retinopathy (DR) in Patients with DME. The recommended dose for EYLEA is 2 mg (0.05 mL or 50 microliters) administered by intravitreal injection every 4 weeks (monthly) for the first 5 injections, followed by 2 mg (0.05 mL) via intravitreal injection once every 8 weeks (2 months). Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 week (monthly) dosing after the first ĂĀƬ3!!'/ĨĆ)+*0$/ĩċ 2.6 Preparation for Administration. EYLEA should be inspected visually prior to administration. If particulates, cloudiness, or discoloration are visible, the vial must not be used. Using aseptic technique, the intravitreal injection should be performed with a 30-gauge x ½-inch injection needle. For complete preparation for administration instructions, see full prescribing information. 2.7 Injection Procedure. The intravitreal injection procedure should be carried out under controlled aseptic conditions, which include surgical hand disinfection and the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a topical broad– spectrum microbicide should be given prior to the injection. Immediately following the intravitreal injection, patients should be monitored for elevation in intraocular pressure. Appropriate monitoring may consist of a check for perfusion of the optic nerve head or tonometry. If required, a sterile paracentesis needle should be available. Following intravitreal injection, patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment (e.g., eye pain, redness of the eye, photophobia, blurring of vision) without delay (see Patient Counseling Information). Each vial should only be used for the treatment of a single eye. If the contralateral eye requires treatment, a new vial should be used and the sterile field, syringe, gloves, drapes, eyelid speculum, filter, and injection needles should be changed before EYLEA is administered to the other eye. After injection, any unused product must be discarded. 3 DOSAGE FORMS AND STRENGTHS Single-use, glass vial designed to provide 0.05 mL of 40 mg/mL solution (2 mg) for intravitreal injection. 4 CONTRAINDICATIONS EYLEA is contraindicated in patients with • Ocular or periocular infections • Active intraocular inflammation • Known hypersensitivity to aflibercept or any of the excipients in EYLEA. Hypersensitivity reactions may manifest as severe intraocular inflammation. 5 WARNINGS AND PRECAUTIONS 5.1 Endophthalmitis and Retinal Detachments. Intravitreal injections, including those with EYLEA, have been associated with endophthalmitis and retinal detachments (see Adverse Reactions). Proper aseptic injection technique must always be used when administering EYLEA. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately (see Dosage and Administration and Patient Counseling Information). 5.2 Increase in Intraocular Pressure. Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including with EYLEA (see Adverse Reactions). Sustained increases in intraocular pressure have also been reported after repeated intravitreal dosing with vascular edothelial growth factor (VEGF) inhibitors. Intraocular pressure and the perfusion of the optic nerve head should be monitored and managed appropriately (see Dosage and Administration). 5.3 Thromboembolic Events. There is a potential risk of arterial thromboembolic events (ATEs) following intravitreal use of VEGF inhibitors, including EYLEA. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). The incidence of reported thromboembolic events in wet AMD studies during the first year was 1.8% (32 out of 1824) in the combined group of patients treated with EYLEA. The incidence in the DME studies from baseline to week 52 was 3.3% (19 out of 578) in the combined group of patients treated with EYLEA compared with 2.8% (8 out of 287) in the control group; from baseline to week 100, the incidence was 6.4% (37 out of 578) in the combined group of patients treated with EYLEA compared with 4.2% (12 out of 287) in the control group. There were no reported thromboembolic events in the patients treated with EYLEA in the first six months of the RVO studies. 6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in the Warnings and Precautions section of the labeling: • Endophthalmitis and retinal detachments • Increased intraocular pressure • Thromboembolic events 6.1 Clinical Trials Experience. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in other clinical trials of the same or another drug and may not reflect the rates observed in practice. A total of 2711 patients treated with EYLEA constituted the safety population in seven phase 3 studies. Among those, 2110 patients were treated with the recommended dose of 2 mg. Serious adverse reactions related to the injection procedure have occurred in <0.1% of intravitreal injections with EYLEA including endophthalmitis and retinal detachment. The most common adverse reactions (*5%) reported in patients receiving EYLEA were conjunctival hemorrhage, eye pain, cataract, vitreous floaters, intraocular pressure increased, and vitreous detachment. Neovascular (Wet) Age-Related Macular Degeneration (AMD). The data described below reflect exposure to EYLEA in 1824 patients with wet AMD, including 1223 patients treated with the 2-mg dose, in 2 double-masked, active-controlled clinical studies (VIEW1 and VIEW2) for 12 months. Table 1: Most Common Adverse Reactions (*1%) in Wet AMD Studies Active Control EYLEA Adverse Reactions (ranibizumab) (N=1824) (N=595) Conjunctival hemorrhage 25% 28% Eye pain 9% 9% Cataract 7% 7% Vitreous detachment 6% 6% Vitreous floaters 6% 7% Intraocular pressure increased 5% 7% Ocular hyperemia 4% 8% Corneal epithelium defect 4% 5% Detachment of the retinal pigment 3% 3% epithelium Injection site pain 3% 3% Foreign body sensation in eyes 3% 4% Lacrimation increased 3% 1% Vision blurred 2% 2% Intraocular inflammation 2% 3% Retinal pigment epithelium tear 2% 1% Injection site hemorrhage 1% 2% Eyelid edema 1% 2% Corneal edema 1% 1% Less common serious adverse reactions reported in <1% of the patients treated with EYLEA were hypersensitivity, retinal detachment, retinal tear, and endophthalmitis. Macular Edema Following Retinal Vein Occlusion (RVO). The data described below reflect 6 months exposure to EYLEA with a monthly 2 mg dose in 218 patients following CRVO in 2 clinical studies (COPERNICUS and GALILEO) and 91 patients following BRVO in one clinical study (VIBRANT). Table 2: Most Common Adverse Reactions (*1%) in RVO Studies Adverse Reactions CRVO BRVO EYLEA Control EYLEA Control (N=218) (N=142) (N=91) (N=92) Eye pain 13% 5% 4% 5% Conjunctival hemorrhage 12% 11% 20% 4% Intraocular pressure increased 8% 6% 2% 0% Corneal epithelium defect 5% 4% 2% 0% Vitreous floaters 5% 1% 1% 0% Ocular hyperemia 5% 3% 2% 2% Foreign body sensation in eyes 3% 5% 3% 0% Vitreous detachment 3% 4% 2% 0% Lacrimation increased 3% 4% 3% 0% Injection site pain 3% 1% 1% 0% Vision blurred 1% <1% 1% 1% Intraocular inflammation 1% 1% 0% 0% Cataract <1% 1% 5% 0% Eyelid edema <1% 1% 1% 0% Less common adverse reactions reported in <1% of the patients treated with EYLEA in the CRVO studies were corneal edema, retinal tear, hypersensitivity, and endophthalmitis. Diabetic Macular Edema (DME). The data described below reflect exposure to EYLEA in 578 patients with DME treated with the 2-mg dose in 2 double-masked, controlled clinical studies (VIVID and VISTA) from baseline to week 52 and from baseline to week 100. Table 3: Most Common Adverse Reactions (*1%) in DME Studies Adverse Reactions Baseline to Week 52 Baseline to Week 100 EYLEA Control EYLEA Control (N=578) (N=287) (N=578) (N=287) Conjunctival hemorrhage 28% 17% 31% 21% Eye pain 9% 6% 11% 9% Cataract 8% 9% 19% 17% Vitreous floaters 6% 3% 8% 6% Corneal epithelium defect 5% 3% 7% 5% Intraocular pressure increased 5% 3% 9% 5% Ocular hyperemia 5% 6% 5% 6% Vitreous detachment 3% 3% 8% 6% Foreign body sensation in eyes 3% 3% 3% 3% Lacrimation increased 3% 2% 4% 2% Vision blurred 2% 2% 3% 4% Intraocular inflammation 2% <1% 3% 1% Injection site pain 2% <1% 2% <1% Eyelid edema <1% 1% 2% 1% Less common adverse reactions reported in <1% of the patients treated with EYLEA were hypersensitivity, retinal detachment, retinal tear, corneal edema, and injection site hemorrhage. 6.2 Immunogenicity. As with all therapeutic proteins, there is a potential for an immune response in patients treated with EYLEA. The immunogenicity of EYLEA was evaluated in serum samples. The immunogenicity data reflect the percentage of patients whose test results were considered positive for antibodies to EYLEA in immunoassays. The detection of an immune response is highly dependent on the sensitivity and specificity of the assays used, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to EYLEA with the incidence of antibodies to other products may be misleading. In the wet AMD, RVO, and DME studies, the pre-treatment incidence of immunoreactivity to EYLEA was approximately 1% to 3% across treatment groups. After dosing with EYLEA for 24-100 weeks, antibodies to EYLEA were detected in a similar percentage range of patients. There were no differences in efficacy or safety between patients with or without immunoreactivity. 6.3 Postmarketing Experience. The following adverse reactions have been identified during postapproval use of EYLEA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. • Hypersensitivity including rash, pruritus, and urticaria as well as isolated cases of severe anaphylactic/anaphylactoid reactions. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy. Pregnancy Category C. Aflibercept produced embryo-fetal toxicity when administered every three days during organogenesis to pregnant rabbits at intravenous doses *3 mg per kg, or every six days at subcutaneous doses *0.1 mg per kg. Adverse embryo-fetal effects included increased incidences of postimplantation loss and fetal malformations, including anasarca, umbilical hernia, diaphragmatic hernia, gastroschisis, cleft palate, ectrodactyly, intestinal atresia, spina bifida, encephalomeningocele, heart and major vessel defects, and skeletal malformations (fused vertebrae, sternebrae, and ribs; supernumerary vertebral arches and ribs; and incomplete ossification). The maternal No Observed Adverse Effect Level (NOAEL) in these studies was 3 mg per kg. Aflibercept produced fetal malformations at all doses assessed in rabbits and the fetal NOAEL was less than 0.1 mg per kg. Administration of the lowest dose assessed in rabbits (0.1 mg per kg) resulted in systemic exposure (AUC) that was approximately 10 times the systemic exposure observed in humans after an intravitreal dose of 2 mg. There are no adequate and well-controlled studies in pregnant women. EYLEA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Females of reproductive potential should use effective contraception prior to the initial dose, during treatment, and for at least 3 months after the last intravitreal injection of EYLEA. 8.3 Nursing Mothers. It is unknown whether aflibercept is excreted in human milk. Because many drugs are excreted in human milk, a risk to the breastfed child cannot be excluded. EYLEA is not recommended during breastfeeding. A decision must be made whether to discontinue nursing or to discontinue treatment with EYLEA, taking into account the importance of the drug to the mother. 8.4 Pediatric Use. The safety and effectiveness of EYLEA in pediatric patients have not been established. 8.5 Geriatric Use. In the clinical studies, approximately 76% (2049/2701) of patients randomized to treatment with EYLEA were *65 years of age and approximately 46% (1250/2701) were *75 years of age. No significant differences in efficacy or safety were seen with increasing age in these studies. 17 PATIENT COUNSELING INFORMATION In the days following EYLEA administration, patients are at risk of developing endophthalmitis or retinal detachment. If the eye becomes red, sensitive to light, painful, or develops a change in vision, advise patients to seek immediate care from an ophthalmologist (see Warnings and Precautions). Patients may experience temporary visual disturbances after an intravitreal injection with EYLEA and the associated eye examinations (see Adverse Reactions). Advise patients not to drive or use machinery until visual function has recovered sufficiently. Manufactured by: Regeneron Pharmaceuticals, Inc. 777 Old Saw Mill River Road Tarrytown, NY 10591-6707 EYLEA is a registered trademark of Regeneron Pharmaceuticals, Inc. © 2016, Regeneron Pharmaceuticals, Inc. All rights reserved. Issue Date: June 2016 Initial U.S. Approval: 2011 June 2016 MARCH 1, 2017 :: Ophthalmology Times 11 surgery NSAID use after dropless approach can help to lower CME rate Research compares dropless patients with those using traditional drops By Vanessa Caceres; Reviewed by Ahad Mahootchi, MD THE USE OF A NONSTEROIDAL anti-inflammatory drug (NSAID) after dropless cataract surgery lowered the rate of cystoid macular edema (CME) compared with the use of traditional drops, according to a study from Ahad Mahootchi, MD. The dropless approach used in Dr. Mahootchi’s study included triamcinolone acetonide, moxifloxacin hydrochloride, and vancomycin (TMV, Imprimis Pharmaceuticals). Some surgeons may be concerned about using the dropless approach and will often keep a traditional drop to use in the patient’s regimen, noted Dr. Mahootchi, who is in private practice in Zephyrhills, FL. However, it is debatable which drop would be best to keep, which led Dr. Mahootchi and his co-authors to create their research study. In the study, “rates of CME were compared with a prior cohort of 600 consecutive cases who were given steroid and NSAID drops after the surgery without an intravitreal steroid,” he said. The TMV group (n = 600) included patients who received both TMV via a transzonular approach and an NSAID postoperatively. IMPLANTATION ( Continued from page 8 ) “Bent needle and forceps are typically the way to go,” Dr. D’Amico said. > Sterile inflammation is “surprisingly common,” Dr. D’Amico said. “You’ll be afraid that some of these eyes are infected, but many of them are not.” It has typically been treated with peribulbar injection of triamcinolone or dexamethasone, followed by intense topical steroids. > Endophthalmitis can occur. There are new guidelines for checking for Candida colonization, and for preventing infection with this organism, Dr. D’Amico said. Injection of the appropriate antimicrobial agent is the first line of TAKE-HOME in terms of the benefits of dropAll patients were monitored less plus better CME protection,” for CME up to 90 days postopThere was clinically he said. eratively. In patients with visignificant less CME “If using a transzonular stesion of less than 20/30 at the in patients who roid (TMV) at the time of surfinal postoperative visit, clinireceived transgery, adding NSAID drops may cians performed optical coherzonular triamcinolone be better than drops alone at ence tomography. acetonide, preventing CME,” Dr. MahootDr. Mahootchi found a CME moxifloxacin chi said. rate of 1.4% with the use of trahydrochloride, and Although some may believe ditional drops (steroid, NSAID, vancomycin—known the addition of NSAID is expenand antibiotic) versus 0.5% when as the dropless sive, Dr. Mahootchi made an an NSAID was included with approach—in addition arrangement with a local phartranszonular TMV—a clinically to an NSAID after macy to supply generic ketorosignificant difference. cataract surgery. lac. It has been available at a “That surprised me because low cost, lasts enough for both you always hear about older liteyes, and has had no side effects. erature that says with vancoTracking CME rates with this approach is mycin, there’s a higher risk for CME,” Dr. Mahootchi said. “It turns out, it’s better that what ongoing, he added. ■ we were doing before.” BEST OF BOTH WORLDS Dr. Mahootchi has more than 3 years of experience using TMV during surgery and an NSAID after surgery. “This seems to have the best of both worlds treatment, followed by surgery. > Retinal detachment can occur years after implantation. Re-attachment often proves difficult, Dr. D’Amico said. It typically involves pars plana vitrectomy and silicone oil. Although about one-half of these cases can be repaired, fewer patients regain vision. > Choroidal detachment also may occur years after the initial device implantation surgery, Dr. D’Amico said. Some may self-resolve, but treatment with drainage may be appropriate in others. > Vitreous hemorrhage may result from inflammation, intraoperative steroid use, or diabetes, Dr. D’Amico said. Those that do not resolve on their own may require vitrectomy, which is usually quite successful. > Hypotony may be associated with glaucoma drainage devices, choroidal detachment, cho- AHAD MAHOOTCHI, MD E: [email protected] This article was adapted from Dr. Mahootchi’s presentation at the 2016 meeting of the American Society of Cataract and Refractive Surgery. Dr. Mahootchi is a speaker for Imprimis Pharmaceuticals. roidal effusion, or suprachoroidal hemorrhage, Dr. D’Amico said. In cases in which a prior glaucoma tube shunt ligation has not improved IOP, intracameral injection of viscoelastic or vitrectomy and silicone oil tamponade may be employed to restore IOP, Dr. D’Amico said. ■ DONALD J. D’AMICO, MD E: [email protected] This article was adapted from Dr. D’Amico’s presentation of the Pyron Award Lecture at the 2016 meeting of the American Society of Retina Specialists. He did not indicate any proprietary interest in the subject matter. 12 MARCH 1, 2017 :: Ophthalmology Times clinical diagnosis Managing viral eye infection: What clinicians should know Recent observations show variability in disease presentation, host immunity By Lynda Charters; Reviewed by Todd P. Margolis, MD, PhD hough much is occurring in the diagnosis and treatment of viral eye infections, much of it may be under the radar for ophthalmologists. Variability in disease presentation and host immunity—relatively recent observations—are important factors, according to Todd P. Margolis, MD, PhD. Ophthalmologists are perhaps not as aware of these diseases as they should be, and because of this, they can go unrecognized in the clinic, explained Dr. Margolis, the Alan A. and Edith L. Wolff DistinDr. Margolis guished Professor and chairman, Department of Ophthalmology and Visual Science, Washington University, St. Louis. T VA R I C E L L A Z O S T E R V IRUS (V ZV) The incidence and prevalence of chronic and recurrent ocular VZV are unknown, and evaluating referral patients in practice makes it hard to ascertain the actual demographics, Dr. Margolis noted. “Mucous plaque keratopathy—an infectious epithelial keratitis—is found in up to 13% of patients with ocular zoster and can occur years after the initial disease,” he said. “Recurrent iritis and uveitis have been documented in 7.4%, and recurrent keratitis is diagnosed in 6.9%.” The percentage of ocular zoster patients with such complications may be higher, he noted. “Physicians should keep in mind that more antiviral drugs and fewer corticosteroids are needed, in my experience,” Dr. Margolis said. “Patients are referred because of inflammation and are taking more steroids because physicians overlook the infectious component. When I decrease corticosteroids and increase antiviral drugs, patients tend to improve.” ZOSTER SINE HERPETE The degree of skin eruption varies from easily missed lesions to extensive skin eruptions based on the affected structures. When all the branches of the first division of the fifth cranial nerve are involved, very extensive involvement of the skin and eyes may develop. However, if only a single twig of the nasociliary branch of the first division of the trigeminal nerve is involved, there may be ocular involvement (cornea and/or iritis) in the absence of skin eruption (zoster sine herpete), Dr. Margolis noted. A second vaccine, a gE subunit vaccine in a novel adjuvant (HZ/su, GlaxoSmithKline), is causing excitement because of its increased efficacy compared with the first vaccine. While the vaccine has not yet received FDA approval and is currently unavailable, a phase III study (N Engl J Med. 2015;372:2087-2096) reported the vaccine had 97.2% efficacy in preventing shingles and was as effective in patients aged more than 70 years compared with the shingles vaccine in current use in which patients Though much aged more than 70 years did research is happening not benefit as much as younger in the diagnosis patients. TAKE-HOME V Z V, T E M P O R A L ARTERITIS A recent observation is VZV might cause temporal arteritis. A 2015 study (Neurology. and treatment of viral 2015;published online before eye infections, much TORQUE TENO print Feb. 18, 2015) showed 40% of it might not be V IRUS (T T V) of patients with giant cell arreadily apparent This virus is highly prevalent teritis (GCA) had VZV identito clinicians, explains in humans and is on the ocufied by polymerase chain reacTodd P. Margolis, MD, lar surface. The virus reactition, and if many tissue samples PhD. vates in the blood during sepwere obtained and stained, 74% sis and organ transplantation. of patients had VZV antigen in Not much is known about this skip areas, Dr. Margolis noted. “These results suggest, but do not prove, virus, and its exact role in the pathogenesis of diseases is unknown. that VZV causes temporal arteritis,” he said. However, in underscoring the virus’ imporAnother study (JAMA Neurol. 2015;72:12811287) showed VZV antigen in 64% of patients tance, Dr. Margolis recounted the results of a negative for GCA. Similar findings were pub- study in Nepal conducted by his laboratory in lished (Ophthalmology. 2015;122:2142-2145) for which 30 of 32 vitreous taps from patients with patients with anterior ischemic optic neuri- seasonal hyperacute panuveitis were positive tis suspected of having temporal arteritis but for TTV. Another study carried out by Russell with negative biopsies; 5 of 7 patients were Van Gelder, MD, found that sterile taps from patients with endophthalmitis were positive positive for VZV. in 7 of 7 patients for TTV. H E R P E S Z O S T E R VA C C I N E ( H Z V ) Zoster vaccine live (Zostavax, Merck) has been FUCHS’ HETEROCHROMIC available for more than a decade, but most C YC L I T I S (F H C) eligible people have not been vaccinated, Dr. With this virus, 20% to 100% of patients with FHC are positive for intraocular antibodies to Margolis said. Though the vaccine is not perfect, results rubella, according to Dr. Margolis. “This suggests a localized immune response,” have decreased disease incidence and severity. The incidence of zoster has decreased by 51%, he said. Furthermore, 8% to 17% of these paand the incidence of post-herpetic neuralgia tients are positive for rubella RNA. Interestingly, FHC develops less often in pahas decreased by 67%. However, the vaccine probably needs to be repeated after 10 years tients who were vaccinated for rubella, indicating that rubella may cause FHC, he noted. because of reduced efficacy over time. MARCH 1, 2017 :: Ophthalmology Times 13 clinical diagnosis However, some investigators have identified that 8% to 42% of those with FHC have cytomegalovirus (CMV) DNA in the anterior chamber, suggesting that both CMV and rubella may be causative agents of FHC. CMV IRITIS CMV iritis in immune-competent patients is real. Physicians have probably seen it and misdiagnosed it, according to Dr. Margolis. CMV iritis is characterized by unilaterality, masquerades as FHC or Possner-Schlossman syndrome, small corrals of keratoprecipitates, elevated IOP, or iris atrophy, and may be present with/without endothelitis with corneal edema. CMV DNA can be present in the aqueous. The virus responds to ganciclovir and valganciclovir, but not to acyclovir. Over an 8-year span from 2007 to 2015, Dr. Margolis saw 9 men and 6 women (7 Asian, 8 Caucasians) with CMV iritis. Six of 10 patients who underwent vitreous taps were positive for CMV by polymerase chain-reaction assay. Valganciclovir was effective, whereas topical ganciclovir was not. IOP elevations, corneal edema, and anterior chamber reaction were achieved in a mean of 28 days with treatment. When medication was decreased, the CMV recurred in 9 of 10 patients; some were treated for up to 6 years. C L I N I C A L VA R I A B I L I T Y, HOST IMMUNITY The clinical features and outcomes seen with viral disease vary greatly among patients with the same microbe, and what causes this is the most important unresolved question in the infectious disease arena. Investigators point to various factors, such as the viral strain, latency site, or host immunity. Dr. Margolis favors the latter. He discussed the epidemiology of herpes simplex virus (HSV)-1 ARN, a rare disease that occurs in 1 or 2 people per 5 million annually, despite that 80% of individuals have HSV in them. HSV-1 ARN is not an isolated entity. Affected patients also have a high incidence of a second eye disease and central nervous system involvement in addition to chronic iritis and late relapses. “These patients are prone to central HSV infection but not peripheral (skin) disease,” he noted. In a look-back investigation, Dr. Margolis and his colleagues found that of 7 patients with ARN, all also had encephalitis, which raises the question about a genetic component. When considering immune risk factors for HSV, age and atopy are risks for ocular HSV; the C21orf91 genotype is a risk factor for labial HSV, and the TLR2 polymorphisms are risks for HSV encephalitis. “Are these same polymorphisms in these genes responsible for patients who develop HSV-1 ARN?” he asked. This is not isolated to HSV-1 ARN but is apparent in other infectious diseases. “We now understand that highly specific allelic polymorphisms predispose a limited number of individuals to diseases caused by viruses that otherwise only rarely cause overt disease,” he said. “A virus present in all of us may cause disease only in those unfortunate enough to have a specific genetic make-up.” He added that research is showing a number of single gene variants can convey susceptibility or resistance to various pathogens. ■ TODD P. MARGOLIS, MD, PHD E: [email protected] Dr. Margolis has no financial interest in the subject matter.. Built to support your patients, your practice and the American workforce. Skilled, dedicated, and detail-obsessed, Reliance workers take as much pride in their craft as you take in your practice. Which is why you’re able to depend on American-made, industry-leading Reliance chairs, stools, exam equipment and accessories for forward-thinking design, ergonomics, and longevity. Every cut, every stitch, every turn of a tool makes a difference. See more of what we’re made of at BuiltToSupport.com. 800-735-0357 © 2017 Haag-Streit USA. All Rights Reserved. 14 LATEST APPROACHES IN Special Report ) REFRACTIVE SURGERY ADVANCES CONTINUE TO PROGRESS FOR TREATMENT OF REFRACTIVE IRREGULARITIES Wavefront-guided technology (iDesign, Abbott) creates a high-definition scan that measures and maps irregularities that surgeons were not able to see before. The approval with mixed astigmatism helps reach another potential group of patients. (Image courtesy of Abbott) NEW WAVEFRONT INDICATION ENHANCES TREATMENT FOR MIXED ASTIGMATISM Patient segment can be challenging to treat with LASIK By Vanessa Caceres; Reviewed by Robert K. Maloney, MD take-home The approved use of wavefront-guided technology for mixed astigmatism may help ophthalmologists to reach another potential group of patients. P atients with mixed astigmatism can be challenging to treat with LASIK. The recent FDA approval of a new indication for wavefrontguided technology (iDesign Advanced WaveScan Studio System, Abbott) could make treatment for this patient segment a little easier. Used in tandem with an excimer laser system (Star S4 IR, Abbott), the wavefront technology provides surgeons with detailed information for precise and individualized treatment. Previously approved for hyperopia, myopia, and astigmatism, the approval with mixed astigmatism helps reach another potential group of patients, said Robert K. Maloney, MD, Los Angeles. He was involved with FDA trials for the system and has used it for about 4 years. About 5% of his patients have mixed astigmatism. Though eyes within a half-diopter of their target refraction; roughly 90% had 0.50 D or less of astigmatism % 90 this may seem a small percentage, it is a large enough chunk that surgeons would not want to turn them away, he noted. “It’s not terribly common, but if you want to be a comprehensive refractive surgeon, you have to be able to handle those patients,” he said. RISING TO CHALLENGE Mixed astigmatism is probably the hardest refractive error to correct with LASIK, Dr. Maloney noted. “You have to steepen one meridian and flatten the opposite,” he said. “The ablations are more complex in terms of shape. “One challenge is you may not get a full correction,” Dr. Maloney said. “Another challenge is that you may correct the astigmatism well but cause a shift in spherical equivalent that can be myopic or hyperopic. You correct one problem but create another. The [system] offers the possibility of more accurate correction.” Additionally, mixed astigmatism is fairly common after a patient’s original LASIK, he added. A clinical study of the system for mixed astigmatism in 149 eyes found that 91.9% of all eyes had uncorrected visual acuity of 20/20 or better without glasses at 3 months after surgery. Additionally, about 90% of eyes were within a half-diopter of their target refraction, and roughly 90% had 0.50 D or less of astigmatism. “Those are really good results,” especially when up to 5 D of preoperative astigmatism was treated, Dr. Maloney said. The new indication is for mixed astigmatism with a magnitude of 1 D to 5 D of cylinder that is greater than the magnitude of sphere and in which the cylinder and sphere have opposite signs, according to an Abbott press release. Additionally, there must be an agreement between manifest refraction and the system refraction with a magnitude of difference of less than 0.625 D in spherical equivalent and a magnitude of difference of less than or equal to 0.5 D for cylinder. ■ ROBERT K. MALONEY, MD E: [email protected] Dr. Maloney is a consultant for Abbott, Calhoun Vision, and Presbia. MARCH 1, 2017 :: Ophthalmology Times 15 Special Report ) LATEST APPROACHES IN REFRACTIVE SURGERY Handheld polarizing filter augments corneal imaging with simple approach Filter enables surgeons to visualize edge of LASIK flap, collagen lamellae orientation By Cheryl Guttman Krader CIRCULAR POLARIZATION is a polarization imaging of the cornea, Dr. Stesimple and effective technique for corneal vens explained. He has used the technique to visualize imaging that provides valuable clinical information and new insights, according to Julian changes in eyes after intrastromal femtosecond laser astigmatic keratotomy, keratoplasty, D. Stevens, MD. “Ophthalmologists are all familiar with the radial keratotomy, and corneal crosslinking. “Cross polarization reveals the optical and benefits of cross polarization for improving imaging at the slit lamp, but conventionally, biomechanical effects that arise when the corthat would require an instrument with a built- nea is stressed by these surgical incisions or in linear polarizer and use of another hand- after there is contraction post-crosslinking,” he said. “With cross polarization, held polarizer,” said Dr. Stevens, stress within the cornea, the corconsultant ophthalmic surgeon, neal layers, and orientation of the Moorfields Eye Hospital, London. collagen lamellae within the cor“Use of a handheld circular ponea are all visible.” larizing filter gives the desired efUse of a handheld Practical applications include imfect in a much simpler approach circular polarizing filter proved intraoperative assessment which can be used in by any prac- to intercept afferent of corneal suture tension and imtitioner, and I highly recommend and efferent light from proved visualization of the LASIK it to corneal and refractive sur- a slit lamp or operating flap edge in eyes that had excimer geons,” Dr. Stevens said. microscope highlights laser surgery many years earlier. Features within the cornea that corneal structures that “If LASIK was performed many are otherwise hidden are rendered are otherwise invisible years ago, I struggle to see the edge visible, and the imaging technique or barely seen. because the flap is essentially inhighlights stress and biomechanivisible in white light,” Dr. Stevens said. “Even cal effects within the cornea, he noted. “Through the ability to see these changes, with optical coherence tomography (OCT), it can we are better able to measure and understand be very difficult to image the flap, but the flap really ‘lights up’ with circular polarization.” them,” he said. The ability to see how sutures are distorting the cornea is very helpful for ophthalmologists FUNDAMENTAL in training, he noted. PRINCIPLE “When trainees are in their learning phase, The photoelastic effect or stress birefringence was first described in 1816 by Scottish physicist, we simply hold the polarizing filter under the operating microscope so they can see the tenSir David Brewster, according to Dr. Stevens. “Brewster noted that optically isotropic or sion that has been created and adjust the suanisotropic transparent substances become bire- tures as needed,” he said. Dr. Stevens acknowledged the contributions fringent when subjected to mechanical stress,” he said. “Cross polarization takes advantage of Gary Mission, MD, PhD, optical engineer and of the strong polarizing effect of the cornea consultant ophthalmic surgeon, Warwickshire that arises from the arrangement of the col- Hospital, Leamington Spa, England, for developing the imaging technique. ■ lagen fibrils throughout its different layers.” take-home IMPLEMENTATION, APPLICATIONS The technique can be performed in the office at the slit lamp using a handheld circular polarizing filter which intercepts the afferent and efferent light. By rotating the polarization planes, the filter provides effective cross JULIAN D. STEVENS, MD E: [email protected] This article was adapted from Dr. Stevens’ presentation at the 2016 meeting of the American Society of Cataract and Refractive Surgery. Dr. Stevens has no relevant financial interests to disclose. OphthalmologyTimes.com Online Exclusive + UNDERSTANDING PROS, CONS OF LATEST CORNEAL REFRACTIVE PROCEDURE There are numerous reasons refractive surgeons may want to consider small-incision lenticule extraction (SMILE) to treat myopia, including its very high patient satisfaction rate and benefits compared with LASIK. Go to OphthalmologyTimes.com/SMILEProsCons + AVOIDING VISION LOSS FROM INFECTIOUS KERATITIS AFTER LVC Infectious keratitis is not a common complication after laser vision correction (LVC), but it can be devastating. Read more about a case involving a patient who was hit in the eye with a banana 10 years postLASIK. Go to OphthalmologyTimes.com/VisionLoss + LOOKING TO LONG-RANGE KERATOPROSTHESIS OUTCOMES Findings from a single-surgeon consecutive series including 97 eyes with up to 12 years of follow-up provide realistic insights for corneal surgeons about long-term implantation outcomes. Go to OphthalmologyTimes.com/BostonKPro + ACCELERATED CXL RIVALS CONVENTIONAL TECHNIQUE Conventional and accelerated corneal crosslinking were found to be similarly safe and effective for stabilizing keratoconus progression in eyes with mild-to-moderate disease. Go to OphthalmologyTimes.com/AcceleratedCXL DIISC Proven to treat the signs of inferior corneal staining in 12 weeks and symptoms of eye dryness in 12, 6, and as little as 2. :KKFTCJGNRGFRTQXKFGU[ORVQOTGNKGHHTQOG[GFT[PGUUKPUQOGRCVKGPVUCVYGGMtCPF COGCUWTCDNGTGFWEVKQPKPUKIPUQHKPHGTKQTEQTPGCNUVCKPKPIKPLWUVYGGMU%QPUKFGT:KKFTC VQJGNR[QWT&T['[GRCVKGPVUƂPFVJGTGNKGHVJG[oXGDGGPYCKVKPIHQT Take it all in at Xiidra-ECP.com (QWTTCPFQOK\GFFQWDNGOCUMGFYGGMVTKCNUGXCNWCVGFVJGGHƂECE[CPFUCHGV[QH:KKFTCXGTUWU XGJKENGCUCUUGUUGFD[KORTQXGOGPVKPVJGUKIPU OGCUWTGFD[+PHGTKQT%QTPGCN5VCKPKPI5EQTG CPFU[ORVQOU OGCUWTGFD['[G&T[PGUU5EQTGQH&T['[G&KUGCUG 0 Marks designated ® and ™CTGQYPGFD[5JKTGQTCPCHƂNKCVGFEQORCP[ 5JKTG75+PE.GZKPIVQP/#5 OVER what Dry Eye patients have been waiting for Indication Xiidra® NKƂVGITCUVQRJVJCNOKEUQNWVKQPKU KPFKECVGFHQTVJGVTGCVOGPVQHUKIPUCPFU[ORVQOU QHFT[G[GFKUGCUG &'& 6QCXQKFVJGRQVGPVKCNHQTG[GKPLWT[QTEQPVCOKPCVKQP QHVJGUQNWVKQPRCVKGPVUUJQWNFPQVVQWEJVJGVKRQHVJG UKPINGWUGEQPVCKPGTVQVJGKTG[GQTVQCP[UWTHCEG Important Safety Information %QPVCEVNGPUGUUJQWNFDGTGOQXGFRTKQTVQVJG CFOKPKUVTCVKQPQH:KKFTCCPFOC[DGTGKPUGTVGF OKPWVGUHQNNQYKPICFOKPKUVTCVKQP +PENKPKECNVTKCNUVJGOQUVEQOOQPCFXGTUGTGCEVKQPU TGRQTVGFKPQHRCVKGPVUYGTGKPUVKNNCVKQPUKVG KTTKVCVKQPF[UIGWUKCCPFTGFWEGFXKUWCNCEWKV[1VJGT CFXGTUGTGCEVKQPUTGRQTVGFKPVQQHVJGRCVKGPVU YGTGDNWTTGFXKUKQPEQPLWPEVKXCNJ[RGTGOKCG[GKTTKVCVKQP JGCFCEJGKPETGCUGFNCETKOCVKQPG[GFKUEJCTIGG[G FKUEQOHQTVG[GRTWTKVWUCPFUKPWUKVKU 5CHGV[CPFGHƂECE[KPRGFKCVTKERCVKGPVUDGNQYVJG CIGQH[GCTUJCXGPQVDGGPGUVCDNKUJGF (QTCFFKVKQPCNUCHGV[KPHQTOCVKQP|UGGCEEQORCP[KPI $TKGH5WOOCT[QH5CHGV[+PHQTOCVKQPCPF|(WNN 2TGUETKDKPI+PHQTOCVKQPQP|:KKFTC'%2EQO Rx Only BRIEF SUMMARY: Consult the Full Prescribing Information for complete product information. INDICATIONS AND USAGE Xiidra® NKƂVGITCUVQRJVJCNOKEUQNWVKQPKUKPFKECVGF for the treatment of the signs and symptoms of dry eye FKUGCUG &'& DOSAGE AND ADMINISTRATION Instill one drop of Xiidra twice daily (approximately 12 JQWTUCRCTVKPVQGCEJG[GWUKPICUKPINGWUGEQPVCKPGT Discard the single use container immediately after using in each eye. Contact lenses should be removed prior to VJGCFOKPKUVTCVKQPQH:KKFTCCPFOC[DGTGKPUGTVGF minutes following administration. ADVERSE REACTIONS Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may PQVTGƃGEVVJGTCVGUQDUGTXGFKPRTCEVKEG+PƂXGENKPKECN UVWFKGUQHFT[G[GFKUGCUGEQPFWEVGFYKVJNKƂVGITCUV ophthalmic solution, 1401 patients received at least FQUGQHNKƂVGITCUV QHYJKEJTGEGKXGFNKƂVGITCUV 6JGOCLQTKV[QHRCVKGPVU JCFŰOQPVJUQH VTGCVOGPVGZRQUWTGRCVKGPVUYGTGGZRQUGFVQ NKƂVGITCUVHQTCRRTQZKOCVGN[OQPVJU6JGOCLQTKV[ QHVJGVTGCVGFRCVKGPVUYGTGHGOCNG 6JGOQUV EQOOQPCFXGTUGTGCEVKQPUTGRQTVGFKPQHRCVKGPVU were instillation site irritation, dysgeusia and reduced XKUWCNCEWKV[1VJGTCFXGTUGTGCEVKQPUTGRQTVGFKP VQQHVJGRCVKGPVUYGTGDNWTTGFXKUKQPEQPLWPEVKXCN hyperemia, eye irritation, headache, increased lacrimation, eye discharge, eye discomfort, eye pruritus and sinusitis. USE IN SPECIFIC POPULATIONS Pregnancy 6JGTGCTGPQCXCKNCDNGFCVCQP:KKFTCWUGKPRTGIPCPV women to inform any drug associated risks. Intravenous +8CFOKPKUVTCVKQPQHNKƂVGITCUVVQRTGIPCPVTCVUHTQO RTGOCVKPIVJTQWIJIGUVCVKQPFC[FKFPQVRTQFWEG teratogenicity at clinically relevant systemic exposures. +PVTCXGPQWUCFOKPKUVTCVKQPQHNKƂVGITCUVVQRTGIPCPV rabbits during organogenesis produced an increased incidence of omphalocele at the lowest dose tested, OIMIFC[ HQNFVJGJWOCPRNCUOCGZRQUWTGCV the recommended human ophthalmic dose [RHOD], DCUGFQPVJGCTGCWPFGTVJGEWTXG=#7%?NGXGN5KPEG JWOCPU[UVGOKEGZRQUWTGVQNKƂVGITCUVHQNNQYKPI ocular administration of Xiidra at the RHOD is low, the CRRNKECDKNKV[QHCPKOCNƂPFKPIUVQVJGTKUMQH:KKFTCWUGKP humans during pregnancy is unclear. Animal Data .KƂVGITCUVCFOKPKUVGTGFFCKN[D[KPVTCXGPQWU +8 KPLGEVKQPVQTCVUHTQORTGOCVKPIVJTQWIJIGUVCVKQPFC[ ECWUGFCPKPETGCUGKPOGCPRTGKORNCPVCVKQPNQUU and an increased incidence of several minor skeletal CPQOCNKGUCVOIMIFC[TGRTGUGPVKPIHQNF the human plasma exposure at the RHOD of Xiidra, based on AUC. No teratogenicity was observed in the rat at OIMIFC[ HQNFVJGJWOCPRNCUOCGZRQUWTGCV VJG4*1&DCUGFQP#7%+PVJGTCDDKVCPKPETGCUGF incidence of omphalocele was observed at the lowest FQUGVGUVGFOIMIFC[ HQNFVJGJWOCP RNCUOCGZRQUWTGCVVJG4*1&DCUGFQP#7%YJGP CFOKPKUVGTGFD[+8KPLGEVKQPFCKN[HTQOIGUVCVKQPFC[U through 19. A fetal No Observed Adverse Effect Level 01#'.YCUPQVKFGPVKƂGFKPVJGTCDDKV Lactation 6JGTGCTGPQFCVCQPVJGRTGUGPEGQHNKƂVGITCUVKPJWOCP milk, the effects on the breastfed infant, or the effects on OKNMRTQFWEVKQP*QYGXGTU[UVGOKEGZRQUWTGVQNKƂVGITCUV HTQOQEWNCTCFOKPKUVTCVKQPKUNQY6JGFGXGNQROGPVCNCPF JGCNVJDGPGƂVUQHDTGCUVHGGFKPIUJQWNFDGEQPUKFGTGF along with the mother’s clinical need for Xiidra and any potential adverse effects on the breastfed child from Xiidra. Pediatric Use 5CHGV[CPFGHƂECE[KPRGFKCVTKERCVKGPVUDGNQYVJGCIGQH [GCTUJCXGPQVDGGPGUVCDNKUJGF Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger adult patients. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis: Animal studies have not been conducted VQFGVGTOKPGVJGECTEKPQIGPKERQVGPVKCNQHNKƂVGITCUV Mutagenesis: .KƂVGITCUVYCUPQVOWVCIGPKEKPVJGin vitro #OGUCUUC[.KƂVGITCUVYCUPQVENCUVQIGPKEKPVJGin vivo mouse micronucleus assay. In an in vitro chromosomal aberration assay using mammalian cells (Chinese JCOUVGTQXCT[EGNNUNKƂVGITCUVYCURQUKVKXGCVVJGJKIJGUV concentration tested, without metabolic activation. Impairment of fertility: .KƂVGITCUVCFOKPKUVGTGFCV KPVTCXGPQWU +8FQUGUQHWRVQOIMIFC[ HQNFVJGJWOCPRNCUOCGZRQUWTGCVVJG TGEQOOGPFGFJWOCPQRJVJCNOKEFQUG 4*1&QH NKƂVGITCUVQRJVJCNOKEUQNWVKQPJCFPQGHHGEVQP fertility and reproductive performance in male and female treated rats. /CPWHCEVWTGFHQT5JKTG75+PE5JKTG9C[.GZKPIVQP/# (QTOQTGKPHQTOCVKQPIQVQYYY:KKFTCEQOQTECNN Marks designated ®CPFvCTGQYPGFD[5JKTG QTCPCHƂNKCVGFEQORCP[ 5JKTG75+PE 752CVGPVU CPFRGPFKPIRCVGPVCRRNKECVKQPU .CUV/QFKƂGF5 MARCH 1, 2017 :: Ophthalmology Times 19 Special Report ) LATEST APPROACHES IN REFRACTIVE SURGERY Pulse technology boosts all-laser PRK for one-step, no-touch ablation Novel technique improves surface smoothness to deliver faster visual recovery By Cheryl Guttman Krader; Reviewed by Diego de Ortueta, MD A TRANSEPITHELIAL PRK (TransPRK) elegance and simplicity of removing the epiprocedure (SmartSurfACE, Schwind eye-tech- thelium with the excimer laser instead of by solutions) provides the benefits of one-step, no- mechanical or chemical debridement, Dr. de touch surface ablation plus rapid visual recovery, Ortueta noted. Absence of a systematized “plug-and-play” said Diego de Ortueta, MD. The technique—performed option for performing the procedure hampered with an excimer laser system its adoption, but that obstacle was overcome (AMARIS) and pulse technol- in 2009 when the manufacturer implemented ogy (SmartPulse Technology single-step TransPRK for the excimer laser. “With this technique, the laser fires the [SPT], both Schwind eye-techsolutions)—is able to create a aspheric PRK treatment profile first and then Dr. de Ortueta smoother corneal surface. With switches to a defined-depth radial PTK mode the novel pulse technology, the laser spots are for aspheric epithelial ablation,” Dr. de Ortudelivered based on a three-dimensional fuller- eta explained. ene structural model of the cornea that accu“The ORK-CAM software of the laser comrately represents the cornea’s curved surface pensates for the slight differences in photoaband allows spots to be placed closer together, lative rates of the stroma and the epithelium, and the applied defined epithelial thickness particularly in the periphery. “The difference in smoothness can be seen profile is based on literature values and mean on electron micrographs,” said Dr. de Ortu- epithelial profiles of large-based populations so that it is thinner at the center and eta, medical director, Aurelios thicker at the periphery,” he said. Augenzentrum, Recklinghausen, Germany. “Laboratory bench test“Treatment without this aspheric ablation would remove about 10 ing shows that compared with the μm of stromal tissue and induce a original software for [the excimer A transepithelial PRK myopic-like correction of approxilaser], SPT reduces surface rough- technique performed mately –0.75 D.” ness by about 60%, from 749 to with proprietary pulse 272 nm local standard deviation.” technology improves The software also takes into account the greater loss of energy for surface smoothness pulses delivered at the periphery DIVING DEEPER to deliver faster visual and the change of the corneal curResults of a retrospective study com- recovery. vature during the treatment. paring two consecutive groups of 125 eyes each that underwent TransPRK with PR EFERR ED TECHNIQUE or without pulse technology showed the benDr. de Ortueta said that TransPRK has become efit of the procedure, Dr. de Ortueta noted. Predictability of the refractive outcome was his excimer laser procedure of choice for reequally good in both groups as was safety, fractive surgery, replacing LASIK. “Epithelial healing and visual recovery occur with no eyes losing 2 or more lines of Snellen visual acuity. At the time of bandage contact much faster . . . compared with traditional PRK lens removal on postoperative day 4, however, or LASEK, and while the healing process after visual acuity was 20/25 or better in 80% of [TransPRK] still takes longer than after LASIK patients in the SmartSurfACE group compared or femto-LASIK, most patients will achieve binwith just 55% of those treated without the new ocular visual acuity of 20/25 or better by day 4,” he said. “Compared with LASIK, however, pulse technology. “In addition, the corneas of the eyes in the the . . . procedure has many advantages.” Outlining its benefits, Dr. de Ortueta exSmartSurfACE group appeared clearer postopplained that it allows a nearly perfect correeratively,” he said. The idea of TransPRK has always been at- spondence between the topography and the tractive to refractive surgeons because of the cornea. In addition, it avoids flap complica- take-home WATCH THE PROCEDURE VIDEO View a surgical case example of how the novel transepithelial PRK (TransPRK) procedure is performed. (Video courtesy of Diego de Ortueta, MD) Go to Ophthalmologytimes.com/PRKPulse tions, related activity restrictions for the patient, and the need for a microkeratome or femtosecond laser. “We still offer LASIK to all individuals who would be appropriate candidates, but we find that the idea of a flapless procedure is very appealing to patients,” Dr. de Ortueta said. TransPRK also induces less biomechanical changes and has a lower risk for causing ectasia compared with LASIK. In addition, surgical time is faster. For example, laser treatment time for a 4 D myopic correction is only 40 seconds, which makes fixation easier for the patient. There is the potential for haze after TransPRK as there is with any surface-ablation procedure, Dr. de Ortueta noted. “We have now treated more than 700 cases with this new technique,” he said. “Even though we do not use mitomycin-C on virgin eyes, we have observed a <1% incidence of clinical significant haze.” ■ DIEGO DE ORTUETA, MD E: [email protected] or [email protected] Dr. de Ortueta is a consultant to Schwind eye-tech-solutions. MARCH 1, 2017 :: Ophthalmology Times 20 Special Report ) LATEST APPROACHES IN REFRACTIVE SURGERY Clinicians coming to terms with dysfunctional lens syndrome Stages a new way to discuss presbyopia, cataract progression, treatment options By Laird Harrison; Reviewed by Daniel S. Durrie, MD THE TERM “dysfunctional lens syndrome” can help physicians educate their patients about the best treatments for presbyopia, cataract, and related conditions, said Daniel S. Durrie, MD. Increasingly, more eye-care professionals are using the new term, he noted. “This is a trend over the last five years, but it has intensified in the last two years,” said Dr. Durrie, Durrie Vision, Overland Park, KS, where, in his practice he does not use the terms “presbyopia” or “lack of accommodation.” One reason for the terminology shift is the discovery that age-related stiffness, discoloration, and lens clouding is a result of increased disulphide bond formations between the crystalline proteins within lens fiber cells, he noted. “People need to know it’s a natural process,” Dr. Durrie said. “It’s an aging change, but we don’t have to put up with it like our parents and grandparents did.” VA R I O U S S T AG E S In stage 1, the stiffening reduces the lens’ ability to focus, the condition commonly referred to as presbyopia. (The term is derived from the ancient Greek words presbus “old man” and ops “eye.”) In this stage, the lens remains clear and colorless, so patients are able to compensate with reading glasses, biofocals, or monovision. This occurs around 43 to 48 years of age. In stage 2, which happens to people in their 50s and 60s, the continuing buildup of disulphide bonds scatters light. With their discolored lenses, people this age need more light to read and their night vision begins to deteriorate. In stage 3, the disulphide bonds have accumulated to the point that significantly less light can pass through, the condition known as a cataract. (The term derives from the Latin cataracta “waterfall” or “portcullis,” and may originally have been used figuratively.) The average age for cataract surgery is 73 years, Dr. Durrie said. A prodrug using lipoic acid to restore vision by breaking down the disulphide bonds (developed by Encore Vision) is now in clinical trials. Perhaps a laser could be developed to do that job, Dr. Durrie said, but these treatments are “down the road.” In the meantime, patients may choose to ing the procedure reversible. Patients who are more than 3 D hyperopic treat stage 1 dysfunctional lens syndrome with contact lenses, glasses, LASIK, PRK, corneal in- may benefit from lens replacement even if they lays, or IOLs. Though none of these approaches are in stage 1, he said. “That’s the best procedure for these patients restores the eye’s ability to accommodate, they increase the patient’s depth-of-focus or create because it stops progression to stage 2 and stage 3,” he said. “A lot of people are going zones with different refractive powers. Conventional LASIK and PRK require cor- for that option because they can.” Lens replacement is also the best option recting one eye for distance and one eye for near vision, which can result in a lack of depth for someone who has progressed to stage 2 or 3, Dr. Durrie said. To educate perception or imbalanced vision patients about these options, Dr. if the difference between correcDurrie often uses material from tions is too great.The sweet spot companies that provide inlays and for most patients is a –1.25 D diflaser surgery. ference, he said. Multifocal LASIK Using dysfunctional “With this new way to talk to creates different power zones for lens syndrome stages, patients, the industry is now renear and distant vision. physicians can discuss sponding with brochures and videos Two corneal inlays are currently a range of treatment for dysfunctional lens syndrome available in the United States (Kamra, options with patients, education,” he said. AcuFocus; Raindrop, ReVision Op- based on clinical New diagnostic equipment helps, tics). The former is polyvinylidene findings and refractive he says, especially the HD analyzer. fluoride ring placed intrasomally error. “It measures ocular scatter so it in the cornea of the nondominant eye, with its small aperture expanding depth shows that if there is loss of quality,” he said. of focus. In contrast to conventional LASIK and “It’s very easy to do. We use it on every paPRK, the inlay does not diminish distance vi- tient in every exam.” Dr. Durrie uses the results to show patients sion, which remains binocular. “The [inlay] has been very popular,” said how light is being scattered from their lenses. Dr. Durrie, who was a clinical investigator for He also listed the Pentacam (Oculus), Galilei the device and has been implanting it for 10 (Ziemer Ophthalmic Systems) and the iTrace years. “I select patients that have good distance (Tracey Technologies) as useful devices. “We do photos of lens to help educate pavision, no astigmatism, and healthy eyes. It tients,” Dr. Durrie said. “Lots of doctors are works very well.” The other inlay, an hydrogel implant, pro- modifying the way they do exams so they can vides multifocal refraction. The strongest cur- better educate patients.” Optometrists are also finding it helpful to talk vature is in the central region, providing near vision. The curvature gradually decreases to- about dysfunctional lens syndrome, he said. “Optometric groups are very enthusiastic ward the periphery, creating regions that proabout this,” he added, “because they can do vide intermediate and distance vision. More corneal inlays are under development, a better job educating their patients and makand “if they get approval, we will be able to ing sure they understand why a new pair of pick different ones for different patients,” he glasses isn’t going to help.” ■ said, adding that no head-to-head trials have yet compared these inlays or either one to any of those still in the pipeline. DANIEL S. DURRIE, MD “Over the next 5 years, we’ll find out which E: [email protected] patients are best for which procedures,” he said. This article was adapted from Dr. Durrie’s presentation at the 2016 meeting of The inlays offer one significant advantage the American Society of Cataract and Refractive Surgery. He did not indicate any over IOL implants: they can be removed, makproprietary interest in the subject matter. take-home MARCH 1, 2017 :: Ophthalmology Times 21 Special Report ) LATEST APPROACHES IN REFRACTIVE SURGERY Exploring laser vision correction for myopia with/without astigmatism Comparative study documents superiority of wavefront-guided LASIK versus SMILE By Cheryl Guttman Krader; Reviewed by Mounir A. Khalifa, MD, PhD RESULTS of a prospective, masked study show significant differences favoring wavefront-guided (WFG) LASIK compared with small-incision lenticule extraction (SMILE) for the treatment of low-to-moderate myopia with or without astigmatism. The study, conducted by Mounir A. Khalifa, MD, PhD, professor of ophthalmology, Tanta University, Tanta, Egypt, and chairman, Horus Vision Correction Center, Alexandria, Egypt, and colleagues, included 110 eyes with spherical equivalent (SE) up to -6 D who were followed for six months after their refractive procedure. All patients but one underwent bilateral surgery. WFG LASIK was performed in 51 eyes of 51 patients with the Star S4 IR excimer laser (Johnson & Johnson Vision [formerly known as Abbott]) using a high-resolution wavefront aberrometer (iDesign system, J &J Vision), mechanical microkeratome (M2, Moria), 6.0 mm optical zone, and 8.0 mm treatment zone. Fifty-nine eyes of 59 patients underwent SMILE using the VisuMax femtosecond laser (Carl Zeiss Meditec) to create a 6.5 mm lenticule. Visual and refractive outcomes were good with both procedures, but WFG LASIK was associated with faster visual recovery as well as better efficacy, safety, and preservation of visual quality with less induction of higherorder aberrations (HOAs). The recovery of UDVA in relation to preoperative CDVA (efficacy index with time) was slower in the SMILE group than in WFG LASIK-treated eyes, and the difference between groups was more prominent in eyes with low myopia than those with moderate myopia. “SMILE offers some advantages compared with LASIK because there is no flap, and we found it to be efficacious and safe for correction of myopia with or without astigmatism,” he said. “However, WFG LASIK remains the state-of-the-art laser vision correction technique,” Dr. Khalifa added. “It offers more predictable outcomes and better aberrometric control and delivers rapid visual recovery and better UCVA outcomes, which [influence] overall [patient] satisfaction.” Dr. Khalifa performed all of the LASIK procedures at the Horus Vision Correction Center. The SMILE procedures were done by Ahmed Ghoneim, MD, professor of ophthalmology, Tanta University, Tanta, Egypt. MEASUR ING LEV EL OF HOA HOAs in both groups were measured with the same high-resolution aberrometer and analyzed for changes from baseline since there were significant differences between groups preoperatively. Compared with WFG LASIK, SMILE induced a significantly higher level of total HOAs and primary coma. Safety analyses showed a significantly higher safety index associated with WFG LASIK (1.20 vs. 0.98) and no loss of CDVA. In the SMILE group, 6.8% of eyes had a one line or greater decrease from baseline CDVA. Measurements of contrast sensitivity at 6 months showed decreases from baseline after both refractive procedures, but the loss was significantly greater after SMILE at the spatial frequencies of 6, 12, and 18 cycles/degree. “Implementation of axial and torsional automatic registration should provide benefits for reducing coma induction and improving astigmatic correction [of SMILE],” Dr. Khalifa said. ■ MOUNIR KHALIFA, MD, PHD E: [email protected] Dr. Khalifa received an unrestricted educational grant from AMO Germany GmbH. Dr. Ghoneim has no relevant financial interest. 22 MARCH 1, 2017 :: Ophthalmology Times drug therapy Tracking infection source after blepharoplasty Infections infrequent with or without ointment; community-acquired MRSA may be culprit By Vanessa Caceres; Reviewed by Mark A. Alford, MD nfections after blepharoplasty are uncommon with or without the use of an antibiotic ointment. However, if infections occur, be suspicious of communityacquired methicillin-resistant Staphylococcus aureus (MRSA), said Mark A. Alford, MD. He made those conclusions based on his prospective, cohort, observational study on the topic.1 When antibiotic ointments are used, the infection rate after blepharoplasty is extremely low, at only 0.2%. However, there are always concerns about contact sensitivity, bacterial resistance, and cost, explained Dr. Alford, North Texas Ophthalmic Plastic Surgery, Fort Worth, TX. Though patients with an ointment allergy may fare fine in the long term, the short-term effects on appearance can be concerning, he said. I TWO GROUPS Dr. Alford’s study compared two similar consecutive groups undergoing upper eyelid blepharoplasty. In the first group, 384 patients who had blepharoplasty between 2011 and 2013 used bacitracin twice a day for a week. The average patient age was 69.2 years old, with a range of 38 to 87 years old. Patients were excluded if they had an obvious allergy or systemic antibiotic use within a week of surgery. The second group included 158 patients who used lubricant eye ointment (Refresh PM, Allergan) twice a day for a week. The average patient age was 69.3 years old, with a range of 30 to 96 years old. Patients were excluded if they had an allergy to previous topical ointments or if they used systemic antibiotics. All surgeries were performed by Dr. Alford at two surgical centers. There was an identical surgical technique and surgical prep in all cases. Preoperative antibiotics were not used. All patients were seen at a week after surgery. In the bacitracin group, 3.65% of patients had an allergic reaction. Symptoms included bilateral erythema, edema, and itching. All cultures were negative. Once the ointment was Patient images showing postoperative day 7 with community-acquired methicillin-resistant Staphylococcus aureus (MRSA) infection. (Photos courtesy of Mark A. Alford, MD) TAKE-HOME increasing every year. I expect discontinued, patients improved. the source was postoperative Only 1 of the 384 patients had Though infection wound contamination from a an infection, which turned out after blepharoplasty community source or self-into be a unilateral non-MRSA is rare, consider oculation from a nasal cavity.” infection. The patient received community-acquired Dr. Alford concluded that oral antibiotics, Dr. Alford said. methicillin-resistant allergic reactions to bacitraIn the lubricant eye ointment Staphylococcus cin were a little lower than group, 10 (6.3%) of patients had aureus. the 8% reported before in the an infection. All infections were dermatology literature. He also culture-positive for communitysaid postoperative infections are acquired MRSA. Nine of 10 infections were bilateral; after 158 patients, the uncommon with/without ointment but if they do occur, suspect community-acquired MRSA. study was discontinued. This research was not meant to promote any Patients with community-acquired MRSA had their sutures removed and were given oral particular antibiotic but to encourage further investigation of this topic, he said. ■ antibiotics, according to their culture. “All resolved without sequelae, but patients were left with hypertrophic scarring,” he said. Dr. Alford did a further analysis of patients Reference 1. Alford M. Infection rates comparing topical antibiotic with infection and found an average age of versus antibiotic free ointment in blepharoplasty 68.2 years old; two had diabetes, there were no surgery. Am J Cosm Surg. 2015;32:149-153. smokers, and there were no previous Staphylococcal infections. The center’s infection rate was only 0.2%, and he and other surgical staff were tested for MRSA but tests were negative. MARK A. ALFORD, MD So, Dr. Alford wanted to know why were E: [email protected] there so many MRSA cases. This article was adapted from Dr. Alford’s presentation at the 2016 meeting of the “It’s not unexpected,” he said. “It’s virulent, American Academy of Ophthalmology. He did not indicate any financial interest in the diverse, and epidemic in the United States. It’s subject matter. See the sharpest image of retinal health. Launched and powered by the publishers of Ophthalmology Times, Modern Retina delivers information on technology and clinical practice essential to your community. Make it your primary resource. ModernRetina.com MARCH 1, 2017 :: Ophthalmology Times 24 drug therapy TOPICAL ( Continued from page 1 ) 10 patients participated, one intravitreal injection of ranibizumab (Lucentis, Genentech) was administered followed by 1 mg/mL of PAN-90806 once daily for 12 weeks. The administration of rescue ranibizumab injections was based on worsening of the visual acuity by 10 letters and findings of increased retinal thickening on optical coherence tomography (OCT), Dr. Cousins explained. A responder to PAN-90806 was defined as a patient who: > did not need rescue therapy with ranibizumab, > was able to continue the topical therapy without signs of toxicity, > showed evidence of a clinical response on imaging that was reviewed by retina specialists masked to the treatment doses and agreement of at least two experts that there was a qualitative clinically relevant response regarding intraand subretinal fluid, blood, lesion, size, and fluorescein leakage, and evidence of a Wisconsin Reading Center quantified anatomic response on OCT and fluorescein angiography. ST U DY F I N DI NG S No treatment-related systemic adverse events developed, according to Dr. Cousins. A dose-dependent keratopathy developed in association with the three highest doses of PAN-90806. However, though the cases were reversible, this prevented the full enrollment of these cohorts. The keratopathy cases were characterized by an irregular surface, fluorescein staining, and occasionally edema and/or pain. Resolution was seen within a few days to weeks after the drop was discontinued. The keratopathy was thought to have resulted from high corneal drug levels with off-target inhibition of the corneal epidermal growth factor receptor in case you missed it (EGFR), which is crucial for corneal epithelial renewal and repair. “This problem has been solved with development of a new suspension formulation that limits drug exposure to the cornea, but still achieves active concentrations in the back of the eye,” Dr. Cousins said. Investigators saw better tolerability with the two lowest doses, 1 and 2 mg/ml instilled once daily. The results from these two cohorts were used to analyze the drug efficacy. The lowest dose was found to have no drug-related corneal adverse events. In the phase I/II study of the 1 and 2 mg/ml doses administered once daily, 10 of 20 eyes required rescue therapy with ranibizumab. One of 20 eyes discontinued therapy because of toxicity. Nine of 20 eyes were considered responders in the stage 1 segment, according to Dr. Cousins. Patients who received the 1 mg/ml dose had a 12-letter increase in vision. Those who received the 2 mg/ml dose lost one letter of vision. At the 8-week time point, both the central subfield thickness and the centerpoint thickness decreased with the 1 and 2 mg/ ml doses, but substantially more with the higher dose. Both the total lesion size and the area of fluorescein leakage decreased with the two lowest doses. Regarding the lesion size, more of an effect was seen with the 2 mg/ml dose at 8 weeks. Regarding fluorescein leakage, a similar effect was seen at 8 weeks with the two doses. RESPONDERS VERSUS NON-R ESPONDERS The baseline differences between the patients who benefited from the PAN-90806 drops provided important clues to candidates for the treatment. “Responders had thinner central subfields on OCT, smaller lesions, and a smaller area of fluorescein leakage,” Dr. Cousins said. He recounted a representative case of a re- Eye bank network has far-reaching impact PAGE 6 Wavefront indication enhances mixed astigmatism PAGE 14 NSAID after dropless approach can help lower CME PAGE 11 Tracking infection source after blepharoplasty PAGE 22 Viral eye infection: What clinicians should know PAGE 12 Making Facebook work for your practice PAGE 26 sponder with an occult lesion with subretinal fluid, moderate thickening, and vision loss at baseline. On day 1, the central subfield thickness was 286 μm and the visual acuity 66 letters on ETDRS vision testing. At week 8, the thickness had decreased to 213 μm. Ultimately, 8 of 10 subjects in the stage 2 maintenance phase of the study completed 12 weeks without the need for rescue ranibizumab injections. Five of the 10 (50%) were considered responders (according to the expert reviewers using the same clinical criteria as in stage 1). NEW FOR MULATION The transscleral route is how topical drugs reach the choroid, Dr. Cousins noted. The key issue for improving the formulation was minimizing corneal exposure to the drug. When the new formulation was analyzed in a primate study, the corneal concentrations were below the level of toxicity in all doses tested. The new formulation showed almost five-fold higher levels in the choroid compared with the formulation used in this study, Dr. Cousins explained. “These results strongly suggest that it is very possible to develop a topical inhibitor of VEGF,” Dr. Cousins said. “If this drug ultimately gets approved, it will revolutionize how we treat patients with neovascular AMD, diabetic retinopathy, and other retinal conditions driven by VEGF.” A phase I/II trial with the next-generation suspension formulation is slated to begin in the second half of 2017. ■ SCOTT COUSINS, MD E: [email protected] Dr. Cousins is a consultant to PanOptica Inc. next issue... 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Reach highly-targeted, market-specific business professionals, industry experts and prospects by placing your ad here! MARCH 1, 2017 :: Ophthalmology Times 29 technology Expanded line of 27-gauge instruments advantageous Smaller-gauge instrumentation offers increased reliability, better safety outcomes By Fred Gebhart; Reviewed by Kevin J. Blinder, MD he portfolio of retinal instruments continues to expand with a growing line of tools offering surgeons improved work efficiency while promoting better surgical outcomes with 27-gauge instruments. “Clinicians generally believe that smaller is better when it comes to retina instruments and, to a certain extent, they are right,” said Kevin J. Blinder, MD. “When you use 27-gauge instruments—which I have been doing a fair bit recently—the surgical wounds are 100% selfsealing,” said Dr. Blinder, The Retina Institute, St. Louis, and professor of clinical ophthalmology and visual sciences, Dr. Blinder Washington University School of Medicine, St. Louis. “I have not seen any leaks in my patients to this point. Using smaller instrumentation is making sutures almost obsolete.” Patients also tend to feel and look better after surgery using the smaller instruments, he said. They tend to be more comfortable on the first postoperative day. Swelling and other vi- T sual signs of surgical trauma can be so minor that some patients look as though they have not undergone anything more invasive than an eye exam. IMPROV ING FROM 2 0 - GAUGE Surgical instrument makers have long been working to reduce instrument size, but materials, technology, and manufacturing techniques have not always been able to meet surgeons’ needs. The standard for most retina instruments was 20-gauge (0.03575 inch nominal exterior diameter) for many years, Dr. Blinder said. Surgeons were initially excited by the first 25-gauge instruments (0.02025 inch diameter), but disappointed at the lack of rigidity and control. The new generation of smaller instruments felt flimsy and difficult to control, resulting in too many less-than-ideal surgical outcomes. The industry then retreated to 23-gauge (0.02825 inch diameter), in which the larger diameter instruments provided more rigidity and greater control. The manufacturing and material lessons learned in the development of 23-gauge instruments were applied to a new Continues on page 30 : 27-gauge A B A. Smaller-gauge instruments (such as the 27-gauge Directional Laser Probe, Bausch + Lomb) have been designed to offer increased rigidity and ease of control. B. The 27-gauge diamond-dusted membrane scraper (Bausch + Lomb) is composed of a diamond-dusted silicone tip and atraumatically facilitates internal limiting membrane peeling. (Photos courtesy of Bausch + Lomb) Advertiser Index Advertiser Alcon Laboratories Inc. 800/862-5266 www.alcon.com Bausch + Lomb 800/227-1427 www.bausch.com Ceatus Media Group 858/454-5505 www.ceatus.com Page CV2, 3, 30, CV3 CV4 Advertiser Page Haag-Streit USA 800/787-5426 www.haag-streit-usa.com 13 Maine Society of Eye Physicians and Surgeons 207/445-2260 www.maineeyemds.com 21 7 Regeneron Pharmaceuticals 914/345-7400 www.regeneron.com OPHTHALMOLOGY TIMES (Print ISSN 0193-032X, Digital ISSN 2150-7333) is published semimonthly except for one issue in Jan, May, Aug and Dec (20 issues yearly) by UBM Medica, 131 W First Street, Duluth, MN 55802-2065. Subscription rates: $200 for one year in the United States & Possessions, Canada and Mexico; all other countries $263 for one year. Pricing includes air-expedited service. 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Canadian addresses to: IMEX Global Solutions, PO Box 25542 London, ON N6C 6B2 CANADA. Printed in the U.S.A. © 2017 UBM. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical including by photocopy, recording, or information storage and retrieval without permission in writing from the publisher. Authorization to photocopy items for internal/educational or personal use, or the internal/educational or personal use of specific clients is granted by UBM for libraries and other users registered with the Copyright Clearance Center, 222 Rosewood Dr. Danvers, MA 01923, 978-750-8400 fax 978-646-8700 or visit http://www.copyright.com online. For uses beyond those listed above, please direct your written request to Permission Dept. fax 440-756-5255 or email: [email protected]. MARCH 1, 2017 :: Ophthalmology Times 30 technology 27-GAUGE ( Continued from page 29 ) generation of 25-gauge tools. The newer iteration of 25-gauge provided a degree of rigidity and ease of control similar to 23-gauge devices, while causing less trauma during surgery. The current generation of 27-gauge instruments feels very similar to 25-gauge. “I don’t see a lot of difference intraoperatively between 25- and 27-gauge, which is a desirable thing,” Dr. Blinder said. “Where I do see the difference is postoperatively, especially during the first day.” The use of 27-gauge instrumentation makes for a less-invasive procedure than with larger gauge instruments, but the availability of 27-gauge products has been somewhat limited, he noted. “These new products offer the control and usability typically provided by 23- and 25-gauge instruments with the added benefits of small size, which may help surgeons work more safely, efficiently, and effectively,” he said. not important,” he said. “What matters is that you have the full armamentarium at your disposal if you are going to switch over to 27-gauge. No matter how you approach any particular case, you need a complete line of instrumentation available.” The use of 27-gauge instrumentation enables a less-invasive procedure than with largergauge instruments, but the availability of 27- KEVIN J. BLINDER, MD P: 314/367-1181 E: [email protected] Dr. Blinder is a consultant for Bausch + Lomb.. USE IN SPECIFIC POPULATIONS A Pregnancy Pregnancy Category C T atogenic effects: Tr Ter T avoprost was teratogenic in rats, at an intravenous (IV) dose up to 10 mcg/kg/day (250 times the maximal recommended human ocular dose (MRHOD), evidenced by an increase in the incidence of skeletal malformations as well as external and visceral malformations, such as fused sternebrae, domed head and hydrocephaly. Tr T avoprost was not teratogenic in rats at IV doses up to 3 mcg/kg/day (75 times the MRHOD), or in mice at subcutaneous doses up to 1 mcg/kg/day (25 times the MRHOD). Tr T avoprost produced an increase in post-implantation losses and a decrease in fetal viability in rats at IV doses > 3 mcg/kg/day (75 times the MRHOD) and in mice at subcutaneous doses > 0.3 mcg/kg/day (7.5 times the MRHOD). In the offspring of female rats that received travoprost subcutaneously from Day 7 of pregnancy to lactation Day 21 at doses of ≥ 0.12 mcg/kg/day (3 times the MRHOD), the incidence of postnatal mortality was increased, and neonatal body weight gain was decreased. Neonatal development was also affected, evidenced by delayed eye opening, pinna detachment and preputial separation, and by decreased motor activity t. BRIEF SUMMARY OF PRESCRIBING INFORMATION A ® DOSAGE AND ADMINISTRATION A The recommended dosage is one drop in the affected eye(s) once daily in the evening. TRAV AVATTAN Z (travoprost ophthalmic solution) should not be administered more than once daily since it has been shown that more frequent administration of prostaglandin analogs may decrease the intraocular pressure lowering effect. Reduction of the intraocular pressure starts approximately 2 hours after the first administration with maximum effect reached after 12 hours. TRAV AVATTAN Z Solution may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart. ® CONTRAINDICATIONS A None WARNINGS AND PRECAUTIONS W Pigmentation T avoprost ophthalmic solution has been reported to cause changes to pigmented tissues. The most Tr frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid) and eyelashes. Pigmentation is expected to increase as long as travoprost is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of travoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation. The long term effects of increased pigmentation are not known. Iris color change may not be noticeable for several months to years. Typicall T y, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with TRAV AVATAN Z (travoprost ophthalmic solution) 0.004% can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly. ® Eyelash Changes TRAV AVATTAN Z Solution may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, thickness, and number of lashes. Eyelash changes are usually reversible upon discontinuation of treatment. ® Intraocular Inflammation TRAV AVATTAN Z Solution should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated. ® Macular Edema Macular edema, including cystoid macular edema, has been reported during treatment with travoprost ophthalmic solution. TRA RAVATTAN Z Solution should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema. ® Angle-closure, Inflammatory orr Neovascular Glaucoma TRA RAVATTAN Z Solution has not been evaluated for the treatment of angle-closure, inflammatory or neovascular glaucoma. ® Bacterial Keratitis There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface. Use with Contact Lenses Contact lenses should be removed prior to instillation of TRAV AVATTAN Z Solution and may be reinserted 15 minutes following its administration. ® ADVERSE REACTIONS Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The most common adverse reaction observed in controlled clinical studies with TRA RAVATTAN (travoprost ophthalmic solution) 0.004% and TRA RAVATTAN Z (tr ( avoprost ophthalmic solution) 0.004% was ocular hyperemia which was reported in 30 to 50% of patients. Up to 3% of patients discontinued therapy due to conjunctival hyperemia. Ocular adverse reactions reported at an incidence of 5 to 10% in these clinical studies included decreased visual acuity, eye discomfort, foreign body sensation, pain and pruritus. Ocular adverse reactions reported at an incidence of 1 to 4% in clinical studies with TRA RAVATTAN or TRA RAVATTAN Z Solutions included abnormal vision, blepharitis, blurred vision, cataract, conjunctivitis, corneal staining, dry eye, iris discoloration, keratitis, lid margin crusting, ocular inflammation, photophobia, subconjunctival hemorrhage and tearing. ® ® ® ( avoprost ophthalmic solution) 0.004% There are no adequate and well-controlled studies of TRA RAVATTAN Z (tr administration in pregnant women. Because animal reproductive studies are not always predictive of human response, TRAV AVATTAN Z Solution should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. ® INDICATIONS A AND USAGE TRAV AVATTAN Z (travoprost ophthalmic solution) 0.004% is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. ® N E W LY AVA I L A B L E INSTRUMENTS A new 27-gauge laser probe (27-gauge Directional Laser Probe, Bausch + Lomb) passes in and out of the cannula in a straight position, reducing the risk of bumping the natural lens when entering the eye. It also provides the ability to work around the posterior pole when applying laser treatment. A technologic innovation uses a moving tube that allows the probe to adjust from straight to a curve of 85° without actuating the fiber toward the retina. Unlike standard straight and curved laser probes, the device gives the surgeon easy access to the extreme anterior periphery, allowing the surgeon greater flexibility and easier access to more of the eye. More small-gauge instruments are becoming readily accessible to surgeons, including 27-gauge forceps, curved and straight laser probes, light pipes, chandeliers, infusion devices, and cannulas. In addition, a smaller-gauge, diamond-dusted membrane scraper (27-gauge Diamond Dusted Membrane Scraper, Bausch + Lomb) also provides ophthalmologists with more device alternatives. The tool’s diamond-dusted silicone tip is designed to atraumatically facilitate the peeling of internal limiting membranes or epiretinal membranes during macular hole or macular pucker surgery. The new instruments have a nominal external diameter of 0.01625 inches. Many surgeons use the instrument to begin the peel and then switch to forceps, although some surgeons, like Dr. Blinder, may seldom use the membrane scraper. “Whether you use any specific instrument is gauge products has been slightly limited. He added that these new products offer the control and usability typically provided by 23and 25-gauge instruments with the added safer benefits of small size. ■ ® Nursing Mothers A study in lactating rats demonstrated that radiolabeled travoprost and/or its metabolites were excreted in milk. It is not known whether this drug or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TRAV AVATAN Z Solution is administered to a nursing woman. ® Pediatric Use Use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use. Geriatric Use No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients. Hepatic and Renal Impairment T avoprost ophthalmic solution 0.004% has been studied in patients with hepatic impairment and also in Tr patients with renal impairment. No clinically relevant changes in hematology, blood chemistry, or urinalysis laboratory data were observed in these patients. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility T o-year carcinogenicity studies in mice and rats at subcutaneous doses of 10, 30, or 100 mcg/kg/day Tw did not show any evidence of carcinogenic potential. However,r at 100 mcg/kg/day, male rats were only treated for 82 weeks, and the maximum tolerated dose (MTD) was not reached in the mouse study. The high dose (100 mcg/kg) corresponds to exposure levels over 400 times the human exposure at the maximum recommended human ocular dose (MRHOD) of 0.04 mcg/kg, based on plasma active drug levels. Tr T avoprost was not mutagenic in the Ames test, mouse micronucleus test or rat chromosome aberration assay. A slight increase in the mutant frequency was observed in one of two mouse lymphoma assays in the presence of rat S-9 activation enzymes. TTravoprost did not affect mating or fertility indices in male or female rats at subcutaneous doses up to 10 mcg/kg/day [250 times the maximum recommended human ocular dose of 0.04 mcg/kg/day on a mcg/kg basis (MRHOD)]. At A 10 mcg/kg/day, the mean number of corpora lutea was reduced, and the post-implantation losses were increased. These effects were not observed at 3 mcg/kg/day (75 times the MRHOD). PATIENT A COUNSELING INFORMATION A Potential for Pigmentation Patients should be advised about the potential for increased brown pigmentation of the iris, which may be permanent. Patients should also be informed about the possibility of eyelid skin darkening, which may be reversible after discontinuation of TRAV AVATTAN Z (travoprost ophthalmic solution) 0.004%. ® Potential for Eyelash Changes Patients should also be informed of the possibility of eyelash and vellus hair changes in the treated eye during treatment with TRAV AVATTAN Z Solution. These changes may result in a disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Eyelash changes are usually reversible upon discontinuation of treatment. ® Handling the Container Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. When to Seek Physician Advice Patients should also be advised that if they develop an intercurrent ocular condition (e.g., trauma or infection), have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, they should immediately seek their physician’s advice concerning the continued use of TRAV AVATTAN Z Solution. ® Use with Contact Lenses Contact lenses should be removed prior to instillation of TRAV AVATTAN Z Solution and may be reinserted 15 minutes following its administration. ® Use with Other Ophthalmic Drugs If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes between applications. Rx Only U.S. Patent Nos. 5,631,287; 5,889,052, 6,011,062; 6,235,781; 6,503,497; and 6,849,253 ® Nonocular adverse reactions reported at an incidence of 1 to 5% in these clinical studies were allergy, angina pectoris, anxiety, arthritis, back pain, bradycardia, bronchitis, chest pain, cold/flu syndrome, depression, dyspepsia, gastrointestinal disorder, headache, hypercholesterolemia, hypertension, hypotension, infection, pain, prostate disorder, sinusitis, urinary incontinence and urinary tract infections. In postmarketing use with prostaglandin analogs, periorbital and lid changes including deepening of the eyelid sulcus have been observed. ALCON LABORATORIES A , INC. Fort Worth, TTexas 76134 USA © 2006, 2010, 2011, 2012 Novartis 10/15 US-TRZ-15-E-0278 CHOOSE TRAVATAN Z® Solution: A POWERFUL START Sustained 30% IOP lowering at 12, 14, and 20 hours post-dose in a 3-month study1,2* Not actual patient TRAVATAN Z® Solution has no FDA-approved therapeutic equivalent available Help patients start strong and stay on track with INDICATIONS AND USAGE TRAVATAN Z® (travoprost ophthalmic solution) 0.004% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Dosage and Administration The recommended dosage is 1 drop in the affected eye(s) once daily in the evening. TRAVATAN Z® Solution should not be administered more than once daily since it has been shown that more frequent administration of prostaglandin analogs may decrease the IOP-lowering effect. TRAVATAN Z® Solution may be used concomitantly with other topical ophthalmic drug products to lower IOP. If more than 1 topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes apart. IMPORTANT SAFETY INFORMATION Warnings and Precautions Pigmentation—Travoprost ophthalmic solution has been reported to increase the pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as travoprost is administered. After discontinuation of travoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. The long-term effects of increased *Study Design: Double-masked, randomized, parallel-group, multicenter non-inferiority comparison of the efficacy and safety of travoprost 0.004% preserved with benzalkonium chloride (BAK) to TRAVATAN Z® Solution after 3 months of treatment in patients with open-angle glaucoma or ocular hypertension. Baseline IOPs were 27.0 mm Hg (n=322), 25.5 mm Hg (n=322), and 24.8 mm Hg (n=322) at 8 AM, 10 AM, and 4 PM for TRAVATAN Z® Solution. At the end of Month 3, the TRAVATAN Z® Solution group had mean IOPs (95% CI) of 18.7 mm Hg (-0.4, 0.5), 17.7 mm Hg (-0.4, 0.6), and 17.4 mm Hg (-0.2, 0.8) at 8 AM, 10 AM, and 4 PM, respectively. Statistical equivalent reductions in IOP (95% confidence interval about the treatment differences were entirely within ±1.5 mm Hg) were demonstrated between the treatments at all study visits during the 3 months of treatment. References: 1. Data on file, 2013. 2. Lewis RA, Katz GJ, Weiss MJ, et al. Travoprost 0.004% with and without benzalkonium chloride: a comparison of safety and efficacy. J Glaucoma. 2007;16(1):98-103. © 2015 Novartis 10/15 US-TRZ-15-E-0278 pigmentation are not known. While treatment with TRAVATAN Z® Solution can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly. Eyelash Changes—TRAVATAN Z® Solution may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, thickness, and number of lashes. Eyelash changes are usually reversible upon discontinuation of treatment. Use With Contact Lenses—Contact lenses should be removed prior to instillation of TRAVATAN Z® Solution and may be reinserted 15 minutes following its administration. Adverse Reactions The most common adverse reaction observed in controlled clinical studies with TRAVATAN Z® Solution was ocular hyperemia, which was reported in 30 to 50% of patients. Up to 3% of patients discontinued therapy due to conjunctival hyperemia. Ocular adverse reactions reported at an incidence of 5 to 10% in these clinical studies included decreased visual acuity, eye discomfort, foreign body sensation, pain, and pruritus. In postmarketing use with prostaglandin analogs, periorbital and lid changes including deepening of the eyelid sulcus have been observed. Use in Specific Populations Use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use. For additional information about TRAVATAN Z® Solution, please see the brief summary of Prescribing Information on the adjacent page.
