The Eylea Injection Prefilled Syringe received the Chemistry, Manufacturing and Controls Prior-Approval Supplement by the Food and Drug Administration (FDA), according to a statement released by Regeneron Pharmaceuticals Inc.
"With eight pivotal Phase 3 trials and millions of injections used around the world, EYLEA sets a high bar for visual acuity and safety across multiple retinal diseases, including wet age-related macular degeneration and diabetic eye diseases," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. "This approval may help doctors more conveniently and efficiently deliver EYLEA to appropriate patients."
Eylea is a vascular endothelial growth factor inhibitor used to block the growth of new blood vessels and decrease the ability of fluid to pass through the blood vessels in the treatment of Neovascular (Wet) Age-related Macular Degeneration, Macular Edema following Retinal Vein Occlusion, Diabetic Macular Edema and Diabetic Retinopathy.
The syringe comes as a sterilized 2 milligram single dose which allows the injection to be easier on both doctor and patient than the currently available Eylea.
