FDA Approves Eylea Injection Prefilled Syringe

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TARRYTOWN, N.Y.—Regeneron Pharmaceuticals announced Tuesday that the U.S. Food and Drug Administration (FDA) has approved the Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for its 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, the company said in a statement.

“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, MD, PhD, president and chief scientific officer of Regeneron. “This approval may help doctors more conveniently and efficiently deliver Eylea to appropriate patients.”

In May, 2019 Regeneron received FDA approval for Eylea as reported by VMAIL. The sterilized prefilled syringe offers the same medicine as Eylea in an easier to use and administer presentation.