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LUCENTIS® Is the First Biologic FDA-Approved for the Treatment of wAMD, Macular Edema Following RVO (RVO), and DME LUCENTIS was specifically designed for use in the eye, and rapid systemic clearance to minimize potential systemic exposure while simultaneously inhibiting intraocular VEGF-A.1,2 The clinical significance of the molecular design of LUCENTIS is not known.1 DISEASE STATE OVERVIEW •W et age-related macular degeneration (wAMD) is a retinal disease that can cause severe and irreversible vision loss.3 • It is a leading cause of blindness in Americans age 60 and over.3 • Retinal vein occlusions (RVOs) are the second most common type of retinal vascular disease and include:4 – Branch RVO (BRVO) – Central RVO (CRVO) • Mean age at onset is 65 years.5 • RVO risk factors include hypertension, diabetes mellitus, arteriosclerosis, and open-angle glaucoma.6 • Diabetic macular edema (DME) is a complication of diabetes mellitus, which is the leading cause of new cases of blindness in adults (ages 20-74 years) in the U.S.7 •R etinopathies like DME are the most frequent microvascular complication of diabetes mellitus.8 •U p to 10% of people with diabetes, or approximately 500,000 Americans, will develop DME during their lifetime.9 •M any patients remain undiagnosed and untreated.10 INDICATIONS AND DOSING LUCENTIS is indicated for the treatment of patients with:1 Neovascular (wet) age-related macular degeneration Macular edema following retinal (wAMD): vein occlusion (RVO): •L UCENTIS 0.5 mg (0.05 mL) is recommended to be •L UCENTIS 0.5 mg (0.05 mL) administered by intravitreal injection once a month (approximately 28 days). •A lthough not as effective, patients may be treated with three monthly doses followed by less frequent dosing with regular assessment. In the nine months after three monthly doses, less frequent dosing with 4-5 doses on average is expected to maintain visual acuity while monthly dosing may be expected to result in an additional average 1-2 letter gain. should be administered by intravitreal injection once a month (approximately 28 days). Diabetic macular edema (DME): •L UCENTIS 0.3 mg (0.05 mL) is recommended to be administered by intravitreal injection once a month (approximately 28 days). PRODUCT EFFICACY LUCENTIS demonstrated clinically meaningful results in wAMD, RVO, and DME. •w AMD: In MARINA, 30% of patients treated with • • • • • monthly LUCENTIS gained ≥15 letters at 2 years compared with 4% of sham-treated patients.1 In ANCHOR, 37% of patients treated with monthly LUCENTIS gained ≥15 letters at 2 years compared with 9% of verteporfin PDT-treated patients.1 10% of treated patients in MARINA experienced a loss ≥15 letters vs. 47% of sham-treated patients, respectively.1 In HARBOR, patients on a less-frequent dosing regimen received an average of 7.7 injections in 12 months resulting in a gain of 8.2 letters, compared to 10.1 letters with 11.3 injections in monthly dosed patients.1,11 In HARBOR, for patients in the less-frequent dosing arm, who were given given 3 initial monthly injections and completed 12 months of the study, 86% did not receive monthly injections.1,14 Patients were assessed regularly.1 •R VO: In BRAVO, 61% of patients treated with monthly LUCENTIS gained ≥15 letters at month 6 compared with 29% of shamtreated patients.1 • In CRUISE, 48% of patients treated with monthly LUCENTIS gained ≥15 letters at month 6 compared with 17% of shamtreated patients.1 • In both BRAVO and CRUISE, treatment with monthly LUCENTIS resulted in rapid increases in mean visual acuity observed as early as 7 days following the initial dose.12,13 • DME: In RIDE and RISE, 39% of patients receiving monthly 0.3 mg LUCENTIS gained ≥15 letters at 24 months compared with 15% of sham-treated* patients.1 •L UCENTIS demonstrated rapid and significant vision improvements at day 7 (+ 4.4 letters) that continued through year 3 (+12.4 letters).15 •L UCENTIS improved or maintained 57.2% of patients’ vision to at least 20/40 at month 24 compared with 36.3% of sham-treated patients.15 * 72% of sham-treated patients received protocol-specified laser treatment vs. 38% of LUCENTIS-treated patients. CONTRAINDICATIONS LUCENTIS is contraindicated in patients with ocular or periocular infections or hypersensitivity to ranibizumab or any of the excipients in LUCENTIS. For additional safety information, please see reverse and accompanying LUCENTIS full prescribing information. CLINICAL EXPERIENCE Genentech is committed to ophthalmology and the continued study of LUCENTIS. The ocular and systemic safety profile of LUCENTIS have been studied in wAMD, RVO, and DME.1 • wAMD: LUCENTIS was FDA approved in 2006 to treat wet AMD based on 3 pivotal trials. • LUCENTIS has been studied in wet AMD for more than a decade in 11 clinical trials and offers 7 years of physician and patient experience.1,14 •R VO: LUCENTIS was FDA approved in •D ME: LUCENTIS was FDA approved in •7 89 trial patients with macular edema •P atients were followed for 3 years. •P rimary endpoints in both clinical trials 2010 to treat macular edema following RVO based on 6-month data from 2 clinical trials. following RVO were studied. 2012 to treat DME based on 2 pivotal trials with a total of 759 trial patients. were measured at 2 years. •P atients were followed for 1 year. • More than 5,500 wet AMD patients have participated in U.S. clinical trials alone.14 NDC AND PRICING NDC* and Wholesale Acquisition Cost (WAC)† HOW SUPPLIED NDC WAC Each LUCENTIS 0.5 mg carton contains a single-use, 2-cc glass vial with a BLUE CAP 50242-0080-01 $1,950 Each LUCENTIS 0.3 mg carton contains a single-use, 2-cc glass vial with a WHITE CAP 50242-0082-01 $1,170 *National Drug Code † Pricing information is current as of October 2012. STORAGE AND HANDLING LUCENTIS should be refrigerated at 2°− 8ºC (36°− 46ºF). DO NOT FREEZE. Do not use beyond the date stamped on the label. LUCENTIS vials should be protected from light. Store in the original carton until time of use. IMPORTANT SAFETY INFORMATION LUCENTIS is contraindicated in patients with ocular or periocular infections or hypersensitivity to ranibizumab or any of the excipients in LUCENTIS. WARNINGS AND PRECAUTIONS Intravitreal injections, including those with LUCENTIS, have been associated with endophthalmitis, retinal detachment, and iatrogenic traumatic cataract. Proper aseptic injection technique should always be utilized when administering LUCENTIS. Patients should be monitored during the week following the injection to permit early treatment, should an infection occur. Increases in intraocular pressure (IOP) have been noted both pre-injection and post-injection (at 60 minutes) with LUCENTIS. IOP and perfusion of the optic nerve head should be monitored and managed appropriately. Although there was a low rate of arterial thromboembolic events (ATEs) observed in the LUCENTIS clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). Fatal events occurred more frequently in DME patients treated monthly with LUCENTIS compared with control. Although the rate of fatal events was low and included causes of death typical of patients with advanced diabetic complications, a potential relationship between these events and intravitreal use of VEGF inhibitors cannot be excluded. ADVERSE EVENTS Serious adverse events related to the injection procedure that occurred in < 0.1% of intravitreal injections included endophthalmitis, rhegmatogenous retinal detachment, and iatrogenic traumatic cataract. In the LUCENTIS Phase III clinical trials, the most common ocular side effects included conjunctival hemorrhage, eye pain, vitreous floaters, and increased intraocular pressure. The most common non-ocular side effects included nasopharyngitis, headache, influenza, sinusitis, cough, and nausea. For additional safety information, please see LUCENTIS full prescribing information. References: 1. LUCENTIS® (ranibizumab injection) full prescribing information. Genentech, Inc, February 2013. 2. Ferrara N, et al. Retina. 2006;26:859-870. 3. National Eye Institute. Facts About Age-Related Macular Degeneration. http://www.nei.nih.gov/health/maculardegen/armd_facts.asp#. Accessed January 25, 2013. 4. Rehak J, Rehak M. Curr Eye Res. 2008;33:111-131. 5. Fegan CD. Eye. 2002;16:98-106. 6. Glacet-Bernard A, et al. Ophthalmology. 1996;103:551-560. 7. Centers for Disease Control and Prevention. National Diabetes Fact Sheet, 2011. http://apps.nccd.cdc.gov/DDTSTRS/FactSheet.aspx. Accessed January 25, 2013. 8. Abbate M, et al. Curr Diabetes Rev. 2011;7(3):190-200. 9. Ali FA. Digital Journal of Ophthalmology. 1997;3(6). www.djo.harvard.edu/site.php?url=/physicians/oa/387. Accessed January 25, 2013. 10. Soliman AZ, et al. Program 1287/ A37 [program abstract]. Presented at the 2011 Association for Vision and Research Annual Meeting: May 2, 2011. 11. Busbee BG, et al. [published online ahead of print January 24 2013]. Ophthalmology. doi:10.1016/j.ophtha.2012.10.014. 12. Campochiaro PA, Heier JS, Feiner L, et al; for BRAVO Study Group. Ophthalmology. 2010;117:1102-1112. 13. Brown DM, et al. Ophthalmology. 2010;117(6):1124-1133. 14. Data on file. Genentech, Inc. 15. Food and Drug Administration. Dermatologic and Ophthalmic Drugs Advisory Committee meeting briefing package for sBLA 125156 LUCENTIS (ranibizumab injection). http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ DermatologicandOphthalmicDrugsAdvisoryCommittee/UCM313089.pdf. Accessed January 28, 2013. ©2013 Genentech, Inc., So. San Francisco, CA LUC0001259301 2/13