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o ph th a l m o l o gy F u tu r e s 2012 E u r o p ean F ORUM C a t a r a c t , G l a u c o ma a nd R e fr a c t iv e S u rg ery Bringing together ophthalmic innovation, financial expertise and corporate leadership 6th September 2012 Hotel Principe di Savoia, Milan, Italy PROGRAMME o phthal m o l o gy F u tu r es 2 0 1 2 European f o r u m Dear participants Welcome to the Ophthalmology Futures 2012 - European Forum. We look forward to a highly stimulating, interactive and informative meeting. Our inaugural European Forum will focus on cataract and intraocular lens technology, refractive surgery, pharmaceuticals and glaucoma devices. Our aim is to present a programme that facilitates discussion between professionals involved in improving ocular health, and present an exclusive environment for business conversation. We hope that the panel sessions led by our eminent faculty, who will discuss the opportunities and challenges of developing drugs and devices in Europe, will motivate you to participate actively. We encourage questions from the floor. In addition, we hope that you will enjoy and gain inspiration from the company presentations which highlight the breadth of innovation which is occurring in the field of ophthalmology. We would like to thank our advisory panel, sponsors and contributors for their invaluable support and assistance. We also look forward to your participation in next year’s Ophthalmology Futures 2013 European Forum, which will be in Amsterdam. Transforming Lives Through Better Vision As the global leader in eye care, Alcon is committed to helping enhance the quality of life by helping people see better. We offer the widest spectrum of surgical, pharmaceutical and vision care products in the industry. Our 24,000 associates partner with eye care professionals to take on the world’s most pressing eye care needs and deliver innovations that reinvent lives. The future of eye care starts with Alcon. Keith Barton Kuldev Singh www.alcon.com © 2012 Novartis Vision Futures Limited, London, UK, registered in England No: 8125858 o p ht ha l m o l o gy F u t ure s T IME 201 2 E u r o p e a n for um TOPI C TIME TOPIC 12:00-12:05Introduction Keith Barton Consultant Ophthalmologist, Moorfields Eye Hospital, London, UK Kuldev Singh Professor of Ophthalmology, Director Glaucoma Service, Stanford University, Stanford, USA Stefano Miglior Head of the Department of Ophthalmology, Policlinico di Monza, University of Milan Bicocca, Italy Gabor Scharioth Senior Consultant, Aurelios Augenzentrum, Recklinghausen, Germany 14:10-14:40 Company presentations: Corneal and Refractive Surgery 12:05-12:50 The Ophthalmic Sector from a European Perspective Chair Chair John Marshall Frost Professor of Ophthalmology, Institute of Ophthalmology, University College, Moorfields Eye Hospital, London, UK AcuFocus Presenters Corina van de Pol Chief Clinical Officer, AcuFocus, USA Panellists Thomas Kohnen Professor of Ophthalmology, Goethe University, Frankfurt, Germany James Mazzo President, Abbott Medical Optics, Senior VP, Abbott Laboratories, USA Paul Rosen Consultant Ophthalmic Surgeon, Oxford Eye Hospital, Oxford, UK Baldo Scassellati Sforzolini VP Global Drug Development, Bausch + Lomb, USA 12:50-13:40 Company presentations: Glaucoma Devices Chair Keith Barton Consultant Ophthalmologist, Moorfields Eye Hospital, London, UK Implandata Ophthalmic Products Presenters Max Ostermeier Founder and CEO, Implandata Ophthalmic Products, Germany InnFocus Len Pinchuk President and CEO, InnFocus, USA EyeTechCare Fabrice Romano CEO, EyeTechCare, France Mark Perry International Sales Director, EyeTechCare, France Aquesys Chris Horvath VP, Research & Development, Aquesys, USA Ivantis Dave Van Meter President and CEO, Ivantis, USA Transcend Medical Brian Walsh President and CEO, Transcend Medical, USA 13:40-14:10 Glaucoma Surgical Innovation: The Present and the Future Chair Kuldev Singh Professor of Ophthalmology, Director Glaucoma Service, Stanford University, Stanford, USA Panellists Stefano Gandolfi Professor, Ophthalmology Clinic, University of Parma, Italy Greg Kunst Global Product Director, Surgical Glaucoma, Alcon, USA Marco Nardi Professor in Ophthalmology and Director, Ophthalmology Department, University of Pisa, Italy Julian Stevens Consultant Ophthalmic Surgeon, Moorfields Eye Hospital, London, UK Refocus Ocular Europe Doug Williamson President and CEO, Refocus Ocular Europe, The Netherlands ReVision Optics John Kilcoyne President and CEO, ReVision Optics, USA 14:40-15:10 Has Refractive Surgery Peaked or is the Best yet to Come? Chair Sheraz Daya Chairman and Medical Director, Centre for Sight. Faculty, University Hospital, Brest, France Panellists Gerd Auffarth Consultant, International Vision Correction Research Centre (IVCRC), University of Heidelberg, Germany Michael Knorz Medical Director, CEO, FreeVis LASIK Group, Mannheim, Germany AIoannis G. Pallikaris Professor in Ophthalmology, School of Medicine, University of Crete, Heraklion, Crete, Greece Julian Stevens Consultant Ophthalmic Surgeon, Moorfields Eye Hospital, London, UK 15:10-15:30 Networking Break 15:30-16:05 Company presentations: Cataract and IOL Technology Chairs David Spalton Consultant Ophthalmologist, King Edward VII Hospital, London, UK Richard Packard Senior Consultant, Prince Charles Eye Unit, Windsor, UK AkkoLens International Presenters Michiel C. Rombach CEO, AkkoLens International, The Netherlands Anew Optics Anna S. Hayes CEO, Anew Optics, USA Aurolab Ravilla Duraisami Sriram Director Operations, Aurolab, India Technolas-Perfect Vision Freider Loesel Chief Strategy Officer, Technolas-Perfect Vision, Germany o p ht ha l m o l o gy F u t ure s T IME 201 2 E u r o p e a n for um TOPI C TIME 16:05-16:30 Who Will Pay? Cataract Innovation and Reimbursement Challenges Chair Paul Rosen Consultant Ophthalmic Surgeon, Oxford Eye Hospital, Oxford, UK Panellists Rafael Chan Director, Global IOL Marketing, Alcon, USA Beatrice Cochener Professor, Chairman, Ophthalmology Department, University Hospital, Brest. President, French Academy of Ophthalmology, France Sheraz Daya Chairman and Medical Director, Centre for Sight. Faculty, University Hospital, Brest, France Ferderic Ernst Director Market Access Europe, Santen, Germany Boris Malyugin Professor of Ophthalmology, Deputy Director General (R&D, Ed) S. Fyodorov Eye Microsurgery State Institution, Russia Andy Stapars Director, Reimbursement and Market Access, Abbott Medical Optics, USA Kaarina Vannas Hospital Mehiläinen, University Eye Hospital, Helsinki Private Eye Hospital, Helsinki, Finland 16:30-17:05 Company presentations: Ophthalmic Pharmaceuticals Chair Stefano Miglior Head of the Department of Ophthalmology, Policlinico di Monza, University of Milan Bicocca, Italy Alimera Sciences Presenters Dan Myers President and CEO, Alimera Sciences, USA Amakem Therapeutics Jack Elands CEO, Amakem Therapeutics, Belgium Icon Bioscience W. Sandy White CEO, Icon Bioscience, USA Ocular Therapeutix Scott Corning VP Sales and Marketing, Ocular Therapeutix, USA 17:05-17:30 Ophthalmic Pharmaceutical Innovation in a Competitive World Chair Carlo E. Traverso Professor and Chairman, Clinica Oculistica Di.N.O.G.M.I., University of Genoa, Italy Panellists Jorge Alio Section Head, Institution Ophthalmology of Alicante, Vissum, Spain Anders Behndig Professor, Department of Clinical Sciences/Ophthalmology, Umeå University Hospital, Umeå, Sweden Gabor Hollo Professor of Ophthalmology, Semmelweis University, Budapest, Hungary Schalon Newton VP, Strategic Marketing and Business Development, Santen, USA TOPIC 17:30-18:00 Ingeborg Stalmans Head of the Glaucoma Unit, Ophthalmology Department, University Hospitals, Leuven, Belgium The Regulatory Environment in Europe versus North America Chair James Mazzo President, Abbott Medical Optics, Senior VP, Abbott Laboratories, USA Panellists Steve Pakola Chief Medical Officer, Amakem Therapeutics, Belgium Sharon Tonetta VP of Global Regulatory Affairs and New Product Development, Bausch + Lomb, USA 18:00-18:20 Networking Break 18:20-19:00 Trials, Tribulations and Pearls for Funding Private Ophthalmic Companies Chair John Marshall Frost Professor of Ophthalmology, Institute of Ophthalmology, University College, Moorfields Eye Hospital, London, UK Matteo Piovella President of the Italian Ophthalmological Society (SOI). Founder and Medical Director of Centro Microchirurgia Ambulatoriale, Monza, Italy Panellists Michael Mrochen Founder and CEO, IROC Science to Innovation, Switzerland Samir Patel President and CEO, Ophthotech, USA Ed Peterson President and CEO, AcuFocus, US Jean-Marc Wismer CEO, Sensimed, Switzerland 19:00-19:25 Beyond the Hype: What Big Companies Really Look for in Acquisitions Chair Julian Stevens Consultant Ophthalmic Surgeon, Moorfields Eye Hospital, London, UK Panellists Leonard Borrmann Divisional VP, Research & Development, Abbott Medical Optics, USA Johanna Knospe VP Business Development & Product Planning Europe, Santen, Germany Dario Paggiarino VP of Retina Development, Alcon, USA Baldo Scassellati Sforzolini VP Global Drug Development, Bausch + Lomb, USA 19:25-19:30 Closing Comments Keith Barton Consultant Ophthalmologist, Moorfields Eye Hospital, London, UK Cocktail Reception Kuldev Singh Professor of Ophthalmology, Director Glaucoma Service, Stanford University, Stanford, USA 19:30-20:30 Yellox... putting a stop † to ocular inflammation fewer drops. less time.* o phthalmology F utures 2012 E ur o pe a n f o r um PROGRAMME SPONSORS PLATINUM Yellox delivers rapid penetration and powerful resolution of ocular inflammation in less time, with highly potent and targeted prostaglandin inhibition in fewer drops, allowing unique twice daily dosing.* Fast‡1-3 Powerful1 Convenient1,4 Well-tolerated§1,4 GOLD Yellox – a new standard in ocular NSAID efficacy Yellox® (bromfenac sodium sesquihydrate) 0.9 mg/ml eye drops, solution. Prescribing Information. Please refer to the Summary of Product Characteristics before prescribing Yellox®. Pharmaceutical form: Eye drops containing 0.9 mg/ml bromfenac (as sodium sesquihydrate) in clear yellow solution; one drop contains approximately 33 micrograms bromfenac. Indication: Treatment of postoperative ocular inflammation following cataract extraction in adults. Dosage and administration: For ocular use. Use in adults, including the elderly: The dose is one drop of Yellox in the affected eye(s) twice daily, beginning the day after cataract surgery and continuing through the first 2 postoperative weeks. The treatment should not exceed 2 weeks as safety data beyond this is not available. Paediatric population: Safety and efficacy in paediatric patients have not been established. Hepatic or renal impairment: Safety and efficacy have not been established in patients with hepatic disease or renal impairment. Contraindications: Known hypersensitivity to bromfenac, any of the excipients, or other non-steroidal anti-inflammatory medicinal products (NSAIDs). History of asthma, urticaria or acute rhinitis precipitated by acetylsalicylic acid or by other medicinal products with prostaglandin synthetase inhibiting activity. Special warnings and precautions: Topical NSAIDs and corticosteroids may both slow or delay healing; their concomitant use may increase this potential. Yellox contains sodium sulphite, which may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible patients. Cross-sensitivity: There is the potential for crosssensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs, so caution is required among patients with a history of sensitivities to these medicinal products. Susceptible persons: In susceptible patients, continued use of topical NSAIDs, including Yellox, may result in potentially sight-threatening complications (epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation). Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and be closely monitored. In at-risk patients, concomitant use of ophthalmic corticosteroids with NSAIDs may increase risk of corneal adverse events. Postmarketing experience with NSAIDs: Patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus and ocular surface diseases (e.g. dry eye syndrome), rheumatoid arthritis or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse reactions. Topical NSAIDs should be used with caution in these patients. There have been reports that ophthalmic NSAIDs may cause increased bleeding of ocular tissues (including hyphaema) in conjunction with ocular surgery. Yellox should therefore be used with caution in patients with known bleeding tendencies or who are receiving other medicinal products that may prolong bleeding time. Ocular infection: An acute ocular infection may be masked by the topical use of anti-inflammatory medicinal products. Excipients: Since Yellox contains benzalkonium chloride, close monitoring is required with frequent or prolonged use. Benzalkonium chloride is known to discolour soft contact lenses, and has been reported to cause eye irritation, punctuate keratopathy and/or toxic ulcerative keratopathy. Special instructions regarding drop instillation: Multiple topical ophthalmic medicinal products should be administered at least 5 minutes apart. Avoid contaminating the dropper-tip and solution, and tightly close the bottle when not in use. Contact lenses should not be worn during treatment with Yellox. Interactions: Formal interaction studies have not been performed, but no interactions with antibiotic eye drops used in conjunction with surgery have been reported. Fertility, pregnancy and lactation: Pregnancy: There are no adequate data from the use of bromfenac in pregnant women, and the potential risk for humans is unknown. In general, the use of Yellox is not recommended during pregnancy unless the benefit outweighs the potential risk. Breast-feeding: It is unknown whether bromfenac or its metabolites are excreted in human milk. The use of Yellox is in general not recommended during breastfeeding unless the benefit outweighs the potential risk. Fertility: No pregnancy testing or contraceptive measures are required. Effects on ability to drive and use machinery: Transient blurring of vision may occur on instillation. If blurred vision occurs at instillation refrain from driving or using machines until vision is clear. Undesirable effects: In clinical trials (n = 973), a total of 3.4% of patients had ≥1 adverse reactions. The most common or most important reactions were abnormal sensation in eye (0.5%), corneal erosion (mild or moderate, 0.4%), eye pruritus (0.4%), eye pain (0.3%) and eye redness (0.3%). Summary of adverse reactions: Uncommon (≥0.1% to <1%): reduced visual acuity, haemorrhagic retinopathy, corneal epithelium defect (reported with QID use, off-label use, QID), corneal erosion (mild or moderate), corneal epithelium disorder, corneal oedema, retinal exudates, eye pain, eyelid bleeding, vision blurred, photophobia , eyelid oedema, eye discharge, eye pruritus, eye irritation, eye redness, conjunctival hyperaemia, abnormal sensation in eye, ocular discomfort, epistaxis, cough, nasal sinus drainage and face swelling. Rare (≥0.01% to <0.1%; isolated reports from post-marketing experience of more than 20 million patients): corneal perforation, corneal ulcer, corneal erosion – serious, scleromalacia, corneal infiltrates, corneal disorder, corneal scar and asthma. Please consult the Summary of Product Characteristics for a full list of side effects. Overdose: If Yellox is accidentally ingested, fluids should be taken to dilute the medicinal product. Pharmaceutical precautions: Do not store above 25°C. Legal Category: POM. Marketing Authorisation Number: EU/1/11/692/001. Marketing Authorisation Holder: Croma Pharma GmbH, Industriezeile 6, A-2100 Leobendorf, Austria. Date of preparation: April 2011. Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk. Adverse events should also be reported to Bausch & Lomb UK Ltd on 01748 828864. References 1. Yellox, Summary of Product Characteristics 2. Donnenfeld ED et al. Ophthalmology 2007; 114(9):1653-62 3. Donnenfeld ED, Donnenfeld A. Int Ophthalmol Clin. 2006; 46(4):21-40 4. Baklayan GA et al. J Ocul Pharmacol Ther. 2008; 24(4):392-8 5. Nevanac, Summary of Product Characteristics: 2009 6. Acular, Summary of Product Characteristics: 16 Feb 2010 7. Voltarol, Summary of Product Characteristics: 04 May 2010 8. Committee for Medicinal Products for Human Use (CHMP) Assessment Report, 17 March 2011 035-2011-04-BMF Date of preparation: June 2011 Yellox is a registered trademark used by Bausch & Lomb Incorporated by permission of Croma Pharma GmbH. Bausch + Lomb is a registered trademark of Bausch & Lomb Incorporated. Yellox is licensed in all EEA member states, not in Switzerland © Bausch & Lomb Incorporated. † Yellox is the first and only twice-daily topical ocular NSAID indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.4 In a large phase III trial, BID Yellox for 14 days controlled ocular inflammation (SOIS=0) in 59.3% of patients vs 26.9% with placebo (<0.0001).3 ‡ Absorption occurs within 15 minutes, with peak aqueous humour concentration at 150–180 minutes;1,2 in a phase III, placebo-controlled trial significant clearance of ocular inflammation was as fast as 3 days in some patients (8.4% with Yellox vs 1.2% with placebo, p=0.0012), with significant efficacy persisting for 4 weeks3 *Yellox has demonstrated clinical efficacy in 2 weeks with BID dosing. Treatment duration & dosing is relative to current clinical standards across Europe as well as older available NSAIDs.1,2,5-7 § Millions of ophthalmic uses and very low incidence of adverse events (such as stinging and burning)1,4,8 o phthalmology F utures 2012 E ur o pe a n f o r um PROGRAMME SPONSORS SILVER For surgeons who surgically treat and manage glaucoma l Ab-interno sub-conjunctival drainage delivered minimally invasively l Clinically proven outflow pathway l Permanent, collagen derived, soft and flexible gelatin implant 26970 Aliso Viejo Pkwy, Suite 200, Aliso Viejo, CA 92656 Tel: 949.450.0250 www.aquesys.com MEDIA SPONSOR o phthalmology F utures 2012 Eur op ea n forum PROGRAMME SPONSORS PLAT I NUM Abbott Medical Optics (AMO) is focused on providing the full range of advanced professionals deliver optimal vision and lifestyle experiences to patients of all ages. Ophthalmic surgical products include intraocular lenses, laser vision correction systems, phacoemulsification systems, viscoelastics and related products used in cataract and refractive surgery. Contact lens and eye care products include disinfecting solutions, enzymatic cleaners, lens rewetting drops and dry eye drops. AMO is headquartered in Santa Ana, California, and employs approximately 3,600 worldwide. For more information, visit www.amo-inc.com refractive technologies and support to help eye THERE’S O N LY O N E care PLATI NUM As the global leader in eye care, Alcon’s mission is to provide innovative products that enhance quality of life by helping people see better. This mission means that Alcon’s more than 24,000 associates strive to make significant contributions to preserve, restore and enhance vision. Through the merger of Novartis and Alcon, uniting the strengths of Alcon, CIBA VISION and Novartis Ophthalmics into one eye care business, Alcon has become the second largest division of Novartis. With these collective resources and scale, Alcon now offers the widest spectrum of eye care products in surgical, pharmaceutical and vision care across 180 markets and runs operations in 75 countries. Alcon has nearly 2,000 people dedicated to research and development around the world working to address the world’s most pressing eye care needs. Our dedication to eye care extends to professional education at a level unmatched in the industry. For more information, visit www.alcon.com Visit booth #N268 to find out how you can lead the way with the KAMRA™ corneal inlay by AcuFocus.™ For more information on AcuFocus Events at ESCRS, download the AcuFocus App in the App Store or scan here: The KAMRA Corneal Inlay TM Figure 1 In a 2009 report on world aging, the United Nations reported the median age for the European continent was 40 years old, a figure which is significantly higher than the global median age of 28. Further the report shared that of the 18 countries worldwide with a median age of 40 years old or higher, 15 are located in Europe.1 Combine that with the fact that the average age of onset for presbyopia in Europe is 45 and 83% of the population will suffer from the disease, and we see that presbyopia is ubiquitous.2 Medical science has not been ignorant of this phenomenon, and after a decade of evolutionary development, the KAMRA corneal inlay (AcuFocusTM) has proven itself as the solution for presbyopia for patients and physicians. After six generations of refinement, the commercial KAMRA inlay is a 3.8mm ring with a central 1.6mm opening. The annulus is made of polyvinyledene fluoride (PVDF), is 5 μm thin and has 8,400 laser-etched micro-perforations arranged in a pseudo-random pattern (Figure 1). This unique hole pattern was designed especially to improve nutrient flow and to reduce light transmission and thus photic phenomenon. Every element of the design has been carefully considered and clinically tested so that the end result is a device that improves focus at a range of distances while allowing for a natural corneal metabolic process. postoperatively, with less dependence on reading glasses.6 This includes daily functions such as reading the newspaper and driving at night. The KAMRA inlay has now been implanted in over 15,000 patients worldwide with excellent clinical and commercial results. Both clinical and commercial results show that with a small aperture inlay implanted monocularly in the non-dominant eye, patients achieve on average, J2 for uncorrected near visual acuity (UNVA) (Figure 2) 20/25 for uncorrected intermediate visual acuity (UIVA) and 20/25 uncorrected distance visual acuity (UDVA) in their inlay eye. Binocularly, UDVA remains constant from pre-op to post-op.3 Data out to four years show that the effect is sustained, that the cornea is stable and the device is biocompatible over time.4 With the inlay, patients are also showing a reduction in reading distance and improvements in reading acuity and reading speed.5 Trials using the latest generation of the inlay show that patients experience little or no reduction in contrast sensitivity and report performing near, intermediate and distance vision tasks with ease Originally intended for emmetropic presbyopes, physicians have found that inlay implantation either with a simultaneous LASIK treatment (CLK) or after a prior LASIK procedure (PLK) is very successful. Six-month results of a study of 630 patients that underwent a PLK procedure showed that 91% of patients reported a reduction in their dependence on reading glasses; and 94% reported satisfaction with their vision without reading glasses. These patients also experienced visual acuity gains equivalent to reported results for emmetropic presbyopes: mean UNVA improvement from J8 to J2, with mean UDVA reducing only one line from 20/16 to 20/20.7 The outstanding track record shows a presbyopia treatment option that improves near and intermediate vision while maintaining distance vision. Perhaps the best endorsement is the numerous physicians that are choosing the KAMRA inlay as the solution to their own presbyopia. Figure 2: Contralateral comparison of mean UNVA for the inlay implanted eye (IE), fellow eye (OE) and both eyes (BE) for a series of 32 patients shows that while the fellow eye continues to lose near acuity over time, both the inlay eye and binocularly patients maintain excellent near vision. o phthalmology F utures 2012 E ur o pe a n f o r um PROGRAMME SPONSORS GOLD AcuFocus™ Inc., a privately held company located in Irvine, California, developed the KAMRA™ inlay for the treatment of near vision loss (presbyopia). The KAMRA inlay is an intra-corneal inlay designed to create a small aperture effect, allowing the eye to see near and intermediate objects more clearly while maintaining distance vision. By applying the “depth-of-focus” principle commonly used in photography, the KAMRA inlay controls light transmission, allowing only central rays to reach the retina through a fixed 1.6mm aperture. More than 15,000 KAMRA inlays have been implanted and it is available for sale in over 40 countries worldwide. The AcuFocus KAMRA inlay is a 2012 Medical Design Excellence Awards® Finalist. For more information about the KAMRA inlay from AcuFocus visit www.AcuFocus.com GOLD Bausch + Lomb, a global company solely dedicated to eye health and one of the best-known and most respected healthcare brands in the world, offers the widest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses (IOLs) and other eye surgery products. After nearly 160 years, Bausch + Lomb has become a global hallmark for innovation and quality. Our talented and motivated colleagues work relentlessly to invent new materials, engineer new technologies and ultimately bring new innovations to help people see better to live better. We market three broad categories of products: Cataract and Vitreoretinal Surgery: We offer a full suite of ophthalmic surgical products, IOLs and delivery systems. Our line of IOLs feature enVista® TORIC, enVista™, Akreos® MICS and Crystalens® AO. Our surgical systems include the Stellaris® and Stellaris® PC line of phacoemulsification and vitrectomy equipment and the VICTUS™ femtosecond laser platform, co-promoted with Technolas Perfect Vision GmbH (TPV). We also offer a full range of surgical instruments and devices, including our signature Storz™ line of instruments and viscosurgical devices, Amvisc® and Amvisc® Plus. Pharmaceuticals: Our products treat a wide range of eye conditions including glaucoma, eye allergies and dry eye. We offer proprietary and generic prescription medicines and OTC treatments. Our prescription products include the NSAID eye drops Yellox, the steroid eye drops Lotemax, the Artelac® dry eye range, the nonselective beta blocker Carteol, and Liposic ointment for dry eye. Leading OTC products include the Ocuvite and PreserVision ocular vitamins brands. Vision Care: Our contact lens offerings span the entire spectrum of wearing modalities and include the Biotrue™ ONEday, PureVision, SofLens, Boston and Optima brands. Our lens care products include United Nations, “World Population Aging 2009”. Dec 2009. Holden BA, Fricke TR, Ho SM, et al. Global vision impairment due to uncorrected presbyopia. Arch Ophthalmol. 2008;126(12):1731-39. 3 Data on file at AcuFocus. 4 Yilmaz et al. Intracorneal Inlay to Correct Presbyopia: Long-Term Results; JCRS July 2011; 37:1275-80. 5 Dexl AK, Seyeddain O, Riha W, Hohensinn M, Hitzl W, Grabner G. Reading performance after implantation of a small-aperture corneal inlay for the surgical correction of presbyopia: Two-year follow-up. J Cataract Refract Surg. 2011;37:525-531. 6 Thompson V. Task performance after implantation of small aperture inlay to improve near vision. Presented at ASCRS Annual Meeting. San Diego, CA, May 2011. 7 Tomita M. Treatment of Post-LASIK Presbyopia with Small Aperture Corneal Inlay: 6-Month Results. Presented at ASCRS Annual Meeting. Chicago, IL, April 2012. 1 2 Biotrue and renu brands of multipurpose solutions for soft contact lenses and Boston products for cleaning GP contact lenses. For more information, visit www.bausch.com o phthalmology F utures 2012 Eur op ea n forum o phthalmology F utures 2012 E ur o pe a n f o r um PROGRAMME SPONSORS PROGRAMME SPONSORS S I LV ER SILVER Amakem is a kinase platform company focusing on ophthalmology and EyeTechCare is developing non-invasive therapeutic medical devices is developing new treatments for serious eye conditions. Amakem’s using HIFU technology (High Intensity Focused Ultrasound). product pipeline is based on its unique ‘Localized Drug Action’ platform which is designed to generate safe and effective novel kinase inhibitors EyeOP1®, the first device developed by the company, was conceived that minimize systemic exposure with the aim of reducing side effects. for the treatment of glaucoma. The EyeOP1® system has been undergoing clinical trials since 2010 and is due to be launched onto Amakem’s lead candidate, AMA0076, is a novel, highly potent Rho Kinase (ROCK) inhibitor targeted at the the market very soon. The device utilizes the UC3® (Ultrasound treatment of glaucoma, a condition which damages the optic nerve resulting in vision loss and ultimately Circular Cyclo-Coagulation) technique which makes it possible to blindness. AMA0076 has been shown in a number of in vivo models to be highly effective in reducing reduce intraocular pressure by coagulating targeted sections of the intraocular pressure (IOP), a major factor in glaucoma, while avoiding hyperemia. Conjunctival hyperemia ciliary body with pinpoint accuracy. is a distressing and dose limiting side effect for patients that has hindered the progress of many otherwise EyeTechCare, 2871 Avenue de l’Europe, 69140 RILLIEUX LA PAPE, France. Phone: +33 4 78 88 09 00, Fax: +33 4 78 97 45 11. Email: [email protected]. Website: www.eyetechcare.com promising glaucoma drugs. Amakem is working to apply the ‘Localized Drug Action’ platform to several other ophthalmology and non-ophthalmology indications such as COPD (Chronic Obstructive Pulmonary Disease), asthma and IBD (inflammatory bowel disease). Amakem is based in Belgium and located in the life sciences incubator “BioVille” at the University of Hasselt. For more information, visit www.amakem.com SILVER S I LV ER Icon Bioscience, Inc., is a privately held biopharmaceutical company AqueSys, Inc. is a privately-held, venture capital funded ophthalmic focused on the development and commercialization of novel ophthalmic company headquartered in Aliso Viejo, California. The company is pharmaceuticals based on its Verisome® drug delivery technology. Icon is focused on the research, development, manufacturing and distribution developing a broad portfolio of clinically superior specialty pharmaceuticals of implantable devices used to surgically treat and manage glaucoma targeting all major ophthalmic indications. patients. AqueSys® was granted CE mark in 2010/2011 for two of Icon has six portfolio products, based on Verisome technology in development. IBI-10090 is in Phase 3 development for the treatment of inflammation associated with cataract surgery. This trial is expected to be The AqueSys® Implant(s) is the first minimally invasive glaucoma procedure designed to safely provide gold completed in late 2012. IBI-20089 for uveitis will enter Phase 3 development standard IOP reduction via an adoptable ab interno procedure that bypasses all potential outflow obstructions in mid-2013. Icon’s glaucoma product, IBI-60090, is scheduled to enter and minimizes postoperative management of complications. A permanent, soft, collagen-derived, gelatin clinical trials in early 2013. The Verisome® drug delivery technology was invented by Dr. Vernon G. its portfolio products, and these and other products are currently being evaluated in several multi-center clinical studies in the US and abroad. implant gently creates diffuse outflow into the eye’s non-dissected Tenon’s and subconjunctival tissue which is a globally accepted and clinically proven drainage location. Wong, founder of Icon. Highly versatile, it is capable of delivering small The straightforward technology and procedure are designed for surgeons who surgically treat and manage molecules, proteins and monoclonal antibodies in a controlled release glaucoma. The minimally invasive approach is both removable and repeatable. Once in the eye, a single manner for up to a year with a single intraocular injection. Icon has also implant is designed to provide significant, long-term IOP control, which may reduce the risk of glaucoma entered into select agreements with multiple international pharmaceutical disease progression in mild, moderate and refractory glaucoma patients. companies. Icon has a strong ever growing global intellectual property AqueSys, Inc., 9834 Research Drive, Irvine, CA 92618. Telephone: +1.949.450.0250. Fax: +1.949.450.0249 estate. Website: www.aquesys.com For more information, visit www.iconbioscience.com o phthalmology F utures 2012 E ur o pe a n f o r um InnFocus MicroShunt™ PROGRAMME SPONSORS SILVER Innovation in biomaterial-driven device design for the treatment of Glaucoma is our Focus… • Proprietary non-inflammatory material (SIBS) • Designed to deliver significant reduction in IOP and medication dependence • Simplified post-op management • CE Mark granted January 2012 InnFocus is a privately-held, venture capital-backed company dedicated to treating glaucoma by reducing intraocular pressure to a safe level with no progression of vision loss. The InnFocus MicroShunt,™ also known as the “MIDI Arrow,” is an ab externo, plate-less glaucoma drainage implant used to shunt aqueous humor from the anterior chamber to a sub-conjunctival/ Tenons flap. The Company’s founders previously developed a novel non-inflammatory inert biomaterial called “SIBS,” which enabled the leading drug eluting coronary stent. SIBS has enjoyed over a decade of human use and was reformulated by InnFocus specifically for the MicroShunt. The MicroShunt (0.35 mm in diameter x 8.5 mm long) has a 70 μm diameter lumen which acts as a flow resistor to drop IOP to a safe level. Small “fins” located on the tube prevent peri-tubular leakage and migration of the device. The reformulated SIBS biomaterial matches the compliance of tissue, assumes the shape of the eye, is atraumatic and non-erosive, dampens pressure spikes, does not interfere with MRI and demonstrates clinically insignificant inflammation and encapsulation. The device was designed to be used in conjunction with Mitomycin C. An ongoing two-year clinical study with over sixty patients uncontrolled on glaucoma medication demonstrates excellent effectiveness in reducing intraocular pressure by 55% with no long-term adverse events and with >85% patients off glaucoma medication at one year. The InnFocus MicroShunt™ is implantable in a simple, safe and fast procedure, in combination with cataract surgery or alone, using techniques very familiar to ophthalmologists. ophthalmologists for the treatment of mild to moderate glaucoma. InnFocus, Inc., 12415 SW 136th Avenue, Unit #3, Miami, Florida, U.S.A. Contact Bruce A. Weber, VP of Regulatory, Clinical and Quality Assurance, Tel. (305)378-2651 ext. 371, Fax (305)378-2652 Email [email protected] Web: www.innovia-llc.com The millimetres Company intends to sell the device to SILVER InnFocus MicroShunt ™ (formerly MIDI Arrow) www.Innovia-llc.com Vice-President, Clinical, Regulatory & QA InnFocus, Inc. 12415 S.W. 136 Ave. Unit 3 Miami, FL 33186 USA Tel: (305) 378-2651, Ext. 371 Email: [email protected] Ernie Edwards Chief Commercial Officer InnFocus, Inc. One Embarcadero Centre, Suite 500 San Francisco, CA 94111 USA Tel: (805) 459-2475 Email: [email protected] DWG-1INF-0174-00R01 Bruce Weber Ivantis, Inc. is a company dedicated to the development of new and innovative solutions for glaucoma. Current therapies for primary open angle glaucoma (POAG) include eye drops, laser therapy, and surgery. But each of these has its limitations. Glaucoma remains the leading cause of blindness worldwide, in need of better treatment alternatives. It is Ivantis’s goal to develop new and effective solutions for ophthalmology specialists and the 70 million people worldwide who are affected by this debilitating and sight-stealing disease. For more information, visit www.invantisinc.com o phthalmology F utures 2012 E ur o pe a n f o r um PROGRAMME SPONSORS SILVER Refocus Group, Inc. is a medical device company engaged in the research and development of treatments for human vision disorders. Our mission is to become the surgical standard of care for presbyopia, primary open-angle glaucoma and ocular hypertension worldwide. Refocus Group’s main product is PresVIEW™, which is a scleral implant used in an innovative procedure to improve and help restore the natural accommodative process of the visual system that has deteriorated in the aging eye. Refocus Group is currently investigating the safety and efficacy of PresVIEW™ in a multi-center clinical study in North America, as yet it does not have FDA approval. In Europe the company is about to commence a multi-center clinical study for presbyopia in addition to a multi-center glaucoma study. PresVIEW™ has CE Mark approval in Europe. For further information on Refocus Group or PresVIEW™, please contact Doug Williamson, CEO, Refocus Group. For more information, visit www.refocus-group.com SILVER ReVision Optics, Incorporated, (RVO) is a privately held corporation headquartered in Lake Forest, California. The company’s main focus is the research and development of minimally invasive implantable devices for the treatment of presbyopia. RVO’s current product portfolio includes the Raindrop™* Near Vision Inlay. Raindrop, which is 2mm in diameter and comprised of approximately 80% water, is placed just beneath the surface of the eye. The Raindrop is as transparent as natural tears and is less than half the thickness of a human hair. The implant procedure takes approximately fifteen minutes, typically results in patients being able to read the newspaper, a menu, or their iPhone® again, in only a few short days. These positive clinical results are reflected in a recent survey, where 93% of the commercial patients expressed satisfaction with their Raindrop experience. The Company is actively pursuing regulatory approvals and market opportunities for the Raindrop worldwide. The Raindrop has received CE mark is headquartered at 25651 Atlantic Ocean Drive, Suite A1, Lake Forest, California www.revisionoptics.com *Caution: Investigational Device. Limited by Federal (United States) law to investigational use. and is authorized 92630. For for more sale in the information European on RVO, Union. please RVO visit o phthalmology F utures 2012 E ur o pe a n f o r um PROGRAMME SPONSORS SILVER Santen is a pharmaceutical company specialized in the development and manufacturing of ophthalmic pharmaceuticals and OTC eye care and headquartered in Osaka, Japan. Founded in 1890, it is the oldest ethical ophthalmic company in the world and today is a fully integrated global company with global R&D, manufacturing and marketing capabilities. Santen is the market leader in ophthalmic pharmaceuticals in Japan and China. In Japan Santen has also ophthalmic surgical and rheumatology business units. The company’s strong identity is perfectly represented by its Core Value: Tenki ni sanyo suru*, meaning we think carefully about what is essential, decide clearly what we should do, and act quickly. With strong marketing bases in Japan, United States and Europe, backed by state-of-the-art manufacturing and R&D capabilities, Santen aims to increase corporate value as a specialty care company that delivers unique products addressing unmet need in eye care to patients worldwide. Santen in Europe Employing about 560 people Santen Europe has a well-developed and internationally integrated network of competencies. The European Strategic HQ, located in Munich, Germany, is the base for the corporate functions of Business Development and Product Planning, Corporate Development, Sales and Marketing, and Regulatory Intelligence. The European Operational HQ located in Tampere, Finland, is where the prestigious Formulation R&D and Manufacturing facility of Santen Europe are located. Corporate functions of Formulation Development, Manufacturing and Quality, Finance and Administration are based here. In December 2011 Santen completed the acquisition of Novagali. The promising pipeline of Novagali seamlessly fits with Santen’s existing portfolio and represents a significant step forward to meet Santen’s long-term growth expectations and to strengthen its global business platform, especially its business franchises in Europe. Novagali has outstanding R&D capabilities with its technology platforms Novasorb® and Eyeject® and is located in Evry, France. For more information please visit the links: www.santen.eu and www.santen.eu/eu/BusinessDevelopment *Santen’s original interpretation of a passage from chapter 22 of Zhongyong (The Doctrine of the Mean) by Confucius, meaning “exploring the secrets and mechanisms of nature in order to contribute to people’s health. SILVER Established in 2003, Sensimed AG is a Swiss company with its principal focus on design, development and commercialization of integrated micro-systems for medical devices. Sensimed was spun off from the well renowned Swiss Federal Institute of Technology (EPFL) and grows within a world-leading cluster for medical devices in the lake of Geneva area (Switzerland). Sensimed has developed a new, patented, non-invasive product that will significantly improve identification and treatment of glaucoma disease by monitoring intraocular pressure around the clock. In 2009 Sensimed received the CE mark for the SENSIMED Triggerfish® system. The company focuses on conducting clinical trials on human beings in well renowned centers worldwide, and initiated controlled commercialization in selected countries. The SENSIMED Triggerfish® is a paradigm shift in ophthalmology and a step forward in glaucoma patient management. The system comprises a soft contact lens embedded with a miniaturized telemetric sensor. A flexible adhesive antenna worn around the eye is connected to a portable recorder and wirelessly connects to the contact lens to continuously acquire monitoring information. The patient can wear the system for up to 24 hours and can perform every day activities – including sleeping. The data collected at the end of the monitoring session provides specialists with previously unknown clinical data in real life conditions, enabling the choice of customized therapy for patients diagnosed with a glaucoma condition. Contact: Jean-Marc Wismer, CEO – [email protected]. For more information visit www.sensimed.ch o phthalmology F utures 2012 E ur o pe a n f o r um PROGRAMME SPONSORS SILVER Transcend Medical is focused on the development of minimally invasive Ophthalmology Times Europe is a comprehensive publication covering all of the latest developments within the ophthalmic industry with a broad focus on cataract, corneal and refractive surgery, as well as glaucoma and vitreoretinal conditions. EnsurE you kEEp up-to-datE with thE currEnt nEws by subscribing to otEuropE today. medical devices for the treatment of glaucoma, the leading cause of adult irreversible blindness. Over 4 million people in the U.S. and roughly 60 million worldwide are afflicted with the disease today and the numbers are expected to grow to nearly 6 million in the U.S. and over 70 million worldwide by the year 2015. The Transcend mission is to change the paradigm in glaucoma treatment by introducing a minimally invasive yet highly effective procedure that will allow for earlier surgical intervention. The flagship Transcend product, the CyPass MicroStent®, is targeted at the largest glaucoma segment - patients with mild-to-moderate glaucoma. The CyPass Micro-Stent is the first ab interno suprachoroidal device intended to lower lOP while reducing or eliminating the need for glaucoma medication. In the U.S. the CyPass Micro-Stent is an investigational device currently being studied in one of the largest, randomized, controlled surgical glaucoma studies ever conducted - the COMPASS multi-center clinical trial (www.compassclinicalstudy.com). It is estimated that as many as 800,000 patients a year could potentially benefit from the CyPass Micro-Stent procedure in the US alone. For more information, visit www.transcendmedical.com Ophthalmology Times Europe – Weekly e-newsletter Providing the latest news on market developments, trends, surveys and industry events, the weekly e-newsletter is delivered to industry professionals worldwide. PROGRAMME SPONSOR MEDIA bEgin a print subscription hErE: www.oteurope.com/subscribe sign up hErE For thE wEEkLy E-nEwsLEttErs: www.oteurope.com/enewssignup Visit thE wEbsitE: www.oteurope.com Ophthalmology Times Europe (OTE) is a leading media resource for the European ophthalmology community. Its products have a broad focus on cataract and refractive surgery, glaucoma and vitreoretinal conditions. In addition to being a forum for surgeons to communicate their clinical knowledge, insight and procedures OTE reports on all major European news, events and industry trends. Its Editorial Advisory Board of key European opinion leaders provides timely coverage and expert opinion on all the latest research findings and issues affecting the industry. It reaches a pan-European audience via print, on the web and directly to the inboxes of Europe’s leading surgeons. www.oteurope.com SAVE THE DATE o p h t h al mo lo gy F ut u r e s 2 0 13 o phthal m o l o gy F u tu r es A dvis o r y p a n e l The Ophthalmology Futures Advisory panel includes: Jorge Alio Section Head, Institution Ophthalmology of Alicante, Vissum, Spain Keith Barton Consultant Ophthalmologist, Moorfields Eye Hospital, London, UK Beatrice Cochener Professor, Chairman, Ophthalmology Department, University Hospital, Brest. President, French Academy of Ophthalmology, France Emmett Cunningham Partner - Clarus Ventures. Adjunct Clinical Professor of Ophthalmology, Stanford University, Stanford, USA Sheraz Daya Chairman and Medical Director, Centre for Sight. Faculty, University Hospital, Brest, France Tuomas Huuhtanen Director of Marketing, Santen, Finland Michael Knorz Medical Director, CEO, FreeVis LASIK Group, Mannheim, Germany John Marshall Frost Professor of Ophthalmology, Institute of Ophthalmology, University College, Moorfields Eye Hospital. Emeritus Professor of Ophthalmology at King’s College, St. Thomas’ Hospital, London, UK Eu ro pean FORUM Bringing together ophthalmic innovation, financial expertise and corporate leadership James Mazzo President, Abbott Medical Optics, Senior VP, Abbott Laboratories, USA Paul Rosen Consultant Ophthalmic Surgeon, Oxford Eye Hospital, Oxford, UK amsterdam October 2013 Visit www.ophthalmology-futures.com for updates Baldo Scassellati Sforzolini VP Global Drug Development, Bausch + Lomb, USA Kuldev Singh Professor of Ophthalmology, Director Glaucoma Service, Stanford University, Stanford, USA Julian Stevens Consultant Ophthalmic Surgeon, Moorfields Eye Hospital, London, UK The organising committee for the Ophthalmology Futures 2012 European Forum Keith Barton SUPPORT I NG I MPRO V E D O C ULAR HEALTH Consultant Ophthalmologist, Moorfields Eye Hospital, London, UK Ophthalmology Futures 2012 European Forum - in partnership with the following organisations and charities. Professor of Ophthalmology, Director Glaucoma Service, Stanford University, Stanford, USA Kuldev Singh Abigail Mackrill Operational Director, Ophthalmology Futures, UK Brigid Barton Director, Vision Futures, UK Secretariat WBR Limited, Tunbridge Wells, UK Moorfields Eye Hospital Vision Futures Limited, London, UK, registered in England No: 8125858