Retinal Physician

JAN-FEB 2017

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© 2016 Genentech USA, Inc. 1 DNA Way, South San Francisco, CA 94080-4990 All rights reserved. LUC/020915/0044(3) 07/16 lucentis.com/hcp Approved for wet AMD, DME, DR with DME, and macular edema following RVO. STRENGTH IN EVIDENCE The effi cacy and safety of LUCENTIS were rigorously studied in 8 pivotal trials 1-8 REFERENCES: 1. LUCENTIS [package insert]. South San Francisco, CA: Genentech, Inc; 2015. 2. Rosenfeld PJ, Brown DM, Heier JS, et al; MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006;355:1419-1431. 3. Brown DM, Michels M, Kaiser PK, Heier JS, Sy JP, Ianchulev T; ANCHOR Study Group. Ranibizumab versus verteporfin photodynamic therapy for neovascular age-related macular degeneration: two-year results of the ANCHOR study. Ophthalmology. 2009;116:57-65. 4. Regillo CD, Brown DM, Abraham P, et al; PIER Study Group. Randomized, double-masked, sham-controlled trial of ranibizumab for neovascular age-related macular degeneration: PIER study year 1. Am J Ophthalmol. 2008;145:239-248. 5. Busbee BG, Ho AC, Brown DM, et al; HARBOR Study Group. Twelve-month efficacy and safety of 0.5 mg or 2.0 mg ranibizumab in patients with subfoveal neovascular age-related macular degeneration. Ophthalmology. 2013;120:1046-1056. 6. Campochiaro PA, Heier JS, Feiner L, et al; BRAVO Investigators. Ranibizumab for macular edema following branch retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmology. 2010;117:1102-1112. 7. Brown DM, Campochiaro PA, Singh RP, et al; CRUISE Investigators. Ranibizumab for macular edema following central retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmology. 2010;117:1124-1133. 8. Nguyen QD, Brown DM, Marcus DM, et al; RISE and RIDE Research Group. Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE. Ophthalmology. 2012;119:789-801. INDICATIONS LUCENTIS® (ranibizumab injection) is indicated for the treatment of patients with: • Neovascular (wet) age-related macular degeneration (wAMD) • Macular edema following retinal vein occlusion (RVO) • Diabetic macular edema (DME) • Diabetic retinopathy (Non Proliferative DR (NPDR) and Proliferative DR (PDR)) with diabetic macular edema (DME) 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 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 patients with DME and DR at baseline 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. Please see brief summary of full prescribing information on adjacent page. The following randomized, double-masked pivotal trials were conducted for the 4 LUCENTIS indications: wAMD: MARINA—Phase III, multicenter, 2-year, sham injection–controlled study; primary end point at 1 year. ANCHOR— Phase III, multicenter, 2-year, active treatment–controlled study; primary end point at 1 year. PIER—Phase IIIb, 2-year, sham injection–controlled study; primary end point at 1 year. HARBOR—Phase III, multicenter, 2-year, active treatment–controlled dose-response study; primary end point at 1 year. RVO: BRAVO—Phase III, multicenter, 1-year, sham injection–controlled study; primary end point at 6 months. CRUISE—Phase III, multicenter, 1-year, sham injection–controlled study; primary end point at 6 months. DME and DR in Patients with DME: RISE—Phase III, multicenter, 3-year, sham injection– controlled study; primary end point at 2 years. RIDE—Phase III, long-term, 3-year, sham injection–controlled study; primary end point at 2 years. 1-8

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