FDA Approves EYLEA® (aflibercept) Injection Prefilled Syringe
Regeneron Pharmaceuticals, Inc. (REGN)
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Source: PR Newswire
TARRYTOWN, N.Y., Aug. 13, 2019 /PRNewswire/ -- EYLEA is the only anti-VEGF approved to treat four retinal conditions with a single dose strength prefilled syringeEYLEA is available in multiple dosing intervals, offering doctors flexibility to address patients' individual needsRegeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that 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
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