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FDA Approves Regeneron's EYLEA Injection Prefilled Syringe - Quick Facts

Biotechnology company Regeneron Pharmaceuticals, Inc. (REGN) announced Tuesday 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.

EYLEA is the only anti- vascular endothelial growth factor (VEGF) approved to treat four retinal conditions with a single dose strength prefilled syringe. It is available in multiple dosing intervals, offering doctors flexibility to address patients' individual needs.

The sterilized prefilled syringe offers the same medicine as the currently available EYLEA, in an easier to use and administer presentation.

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