Regeneron Pharmaceuticals announced that the FDA has approved Eylea (aflibercept) Injection prefilled syringe. The 2 mg, single-dose, sterilized prefilled syringe provides physicians with a new way to administer Eylea that requires fewer preparation steps compared to vials. The approval was made as a Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS).
Market supply of the Eylea prefilled syringe is expected to be available to physicians and patients this year.
“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,” George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer of Regeneron, said in a company news release. “This approval may help doctors more conveniently and efficiently deliver Eylea to appropriate patients.”
The sterilized prefilled syringe offers the same medicine as the currently available Eylea, in an easier to use and administer presentation.
In the United States, Eylea is indicated to treat wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR).