The U.S. Food and Drug Administration (FDA) has approved the Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for Regeneron’s aflibercept injection (Eylea) prefilled syringe.
A 2 mg, single-dose, sterilised prefilled syringe provides specialists with a new way to administer Eylea that requires fewer preparation steps compared to vials.
A 2 mg, single-dose, sterilised prefilled syringe provides specialists with a new way to administer Eylea that requires fewer preparation steps compared to vials
“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.”
The sterilised prefilled syringe offers the same medicine as the currently available Eylea, in an easier to use and administer presentation.
Eylea is indicated to treat neovascular (wet) age-related macular degeneration (Wet AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR).