FDA Accepts Application For Regeneron's Eylea Injection For Macular Edema
By Cyndi Root
Regeneron Pharmaceuticals, Inc. announced in a press release that the Food and Drug Administration (FDA) accepted its application for Eylea. The injectable is for Macular Edema following Branch Retinal Vein Occlusion (BRVO). The standard review is likely to conclude by the end of 2014. George D. Yancopoulos, M.D., Ph. D., Chief Scientific Officer and President of Regeneron Laboratories said, "This is the fourth regulatory submission in the U.S. for Eylea and, if approved, we hope it will provide a new treatment option for patients with macular edema following BRVO."
Eylea is already approved for neovascular Age-related Macular Degeneration (AMD) and Macular Edema following Central Retinal Vein Occlusion (CRVO). The FDA is considering Eylea for Diabetic Macular Edema. Regeneron and Bayer HealthCare are working together to develop and market the Eylea. Regeneron retains sole rights in the U.S. while Bayer shares in international profits.
Macular edema is a condition that occurs when fluid leaks into the macula, the component of the eye responsible for forward vision. Fluid in the macula causes blurry vision. Branch Retinal Vein Occlusion (BRVO) is a type of retinal vein occlusion and more common than the other type, Central Retinal Vein Occlusion (CRVO). BRVO indicates that blood vessels in the main vein are blocked, causing reduced blood flow and retinal hypoxia, which leads to vision loss.
Eylea (aflibercept), also known as VEGF Trap-Eye in the literature, is a fusion protein made up of Human VEGF receptors. It acts like a decoy, trapping growth factors to inhibit VEGF receptors. The agent is packaged in glass vials as a clear, colorless, or yellow solution. Regeneron’s successful application acceptance for BRVO was based on the success of an ongoing Phase III clinical trial. The VIBRANT study includes 183 people with macular edema following BRVO. Enrollees receive Eylea or laser treatment.
About Regeneron and Bayer
Regeneron is a drug development company headquartered in Tarrytown, NY. The company discovers, manufactures, and markets pharmaceuticals for serious conditions including cancer, arthritis, asthma, and eye disease. The Bayer Group is a global company and a subsidiary of Bayer AG based in Leverkusen, Germany. The companies expect the FDA to review the application by October 23, 2014.