EYLEA Injection Demonstrates Significantly Greater Gains In Visual Acuity than Both Bevacizumab And Ranibizumab In NIH-Sponsored Diabetic Macular Edema Study

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Regeneron Pharmaceuticals, Inc.
REGN
today announced that in the National Institutes of Health (NIH) sponsored, Diabetic Retinopathy Clinical Research Network (DRCR.net) comparative effectiveness study in patients with Diabetic Macular Edema (Protocol T), EYLEA® (aflibercept) Injection demonstrated a significantly greater improvement in mean change in best-corrected visual acuity (BCVA) from baseline at 52 weeks compared to both bevacizumab (Avastin® /Genentech) and ranibizumab injection (Lucentis®/Genentech), the primary endpoint of the study. The median number of injections using the protocol-specified retreatment regimen was one fewer in patients treated with EYLEA compared to bevacizumab and ranibizumab. Fewer patients in the EYLEA group received criteria-based macular laser treatments than those treated with bevacizumab and ranibizumab. The rates of most ocular and systemic adverse events (AEs) were similar across the three study groups. The rates of arterial thromboembolic events as defined by the Anti-Platelet Trialists' Collaboration (non-fatal stroke, non-fatal myocardial infarction, and vascular death) in the trial were 2 percent in the EYLEA group, 4 percent in the bevacizumab group and 5 percent in the ranibizumab group. There were more overall cardiovascular events in the ranibizumab group, compared to the EYLEA group and the bevacizumab group (nominal p less than 0.01); this included more cardiac events and cerebrovascular events in the ranibizumab group. DRCR.net has shared these top-line results with study investigators. DRCR.net is in the process of finalizing and verifiying the data prior to submission for publication. Regeneron understands that DRCR.net intends to present the final results at a future medical conference simultaneous to, or soon after, publication, and that the DRCR.net will not be publicly discussing the results prior to publication. "The National Eye Institute and The National Institute of Diabetes and Digestive and Kidney Diseases of the NIH and the DRCR.net should be commended for a carefully designed and well-conducted study," said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. "These data will provide useful information to retinal specialists and their patients to help guide treatment decisions." The independent, government-sponsored study was designed to determine if one of three different anti-VEGF therapies is superior to the others for the treatment of diabetic macular edema (DME). In the study, 660 patients were randomized to receive either EYLEA 2 milligrams (mg), bevacizumab 1.25 mg, or ranibizumab 0.3 mg dosed according to a protocol-specified algorithm. Patients were treated with focal/grid laser at or after the 24 week visit if: 1) the OCT central subfield thickness was greater than or equal to 250 microns or there was edema that was threatening the fovea and 2) the eye did not improve on OCT or visual acuity from the last two consecutive injections. Full details of the protocol can be found at www.drcr.net.
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