FDA Approves EYLEA Injection Prefilled Syringe

Regeneron Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) has approved the Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for the 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. 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," 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 sterilized prefilled syringe offers the same medicine as the currently available EYLEA, in an easier to use and administer presentation.

In the U.S., 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).

EYLEA® (aflibercept) Injection is a vascular endothelial growth factor (VEGF) inhibitor formulated as an injection for the eye. It is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor (PLGF), two growth factors involved in angiogenesis. In the U.S., EYLEA is the market-leading, FDA-approved anti-VEGF treatment for its approved indications and is supported by a robust body of research that includes eight pivotal Phase 3 trials.

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