OSLI Retina

February 2017

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EYLEA is a registered trademark of Regeneron Pharmaceuticals, Inc. ©2016, Regeneron Pharmaceuticals, Inc., All rights reserved 06/2016 777 Old Saw Mill River Road, Tarrytown, NY 10591 US-LEA-1648(1) Strength Please see brief summary of full Prescribing Information on the following page. INDICATIONS AND IMPORTANT SAFETY INFORMATION INDICATIONS EYLEA ® (a ibercept) 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. CONTRAINDICATIONS EYLEA ® (a ibercept) Injection is contraindicated in patients with ocular or periocular infections, active intraocular in ammation, or known hypersensitivity to a ibercept or to any of the excipients in EYLEA. WARNINGS AND PRECAUTIONS Intravitreal injections, including those with EYLEA, have been associated with endophthalmitis and retinal detachments. 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. Intraocular in ammation has been reported with the use of EYLEA. Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including with EYLEA. Sustained increases in intraocular pressure have also been reported after repeated intravitreal dosing with VEGF inhibitors. Intraocular pressure and the perfusion of the optic nerve head should be monitored and managed appropriately. There is a potential risk of arterial thromboembolic events (ATEs) following intravitreal use of VEGF inhibitors, including EYLEA. ATEs are de ned 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 rst 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 rst six months of the RVO studies. ADVERSE REACTIONS 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 oaters, intraocular pressure increased, and vitreous detachment. Choose EYLEA ® (a ibercept) Injection from the start Learn about EYLEA at EYLEA.us/jo As demonstrated in phase 3 clinical trials in patients with Wet AMD, Macular Edema following RVO, DME, and DR in patients with DME Strength Discover in ef cacy

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