Policy & Regulation
Regeneron Pharmaceuticals Inc wins US FDA approval for the EYLEA Injection prefilled syringe for macular degeneration and macular edema
14 August 2019 -

Biotechnology company Regeneron Pharmaceuticals Inc (NASDAQ:REGN) reported on Tuesday the receipt of approval from the US Food and Drug Administration (FDA) for the EYLEA Injection prefilled syringe to treat macular degeneration (Wet AMD) and macular edema.

The US Food and Drug Administration (FDA) has approved the Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for the EYLEA (aflibercept) Injection prefilled syringe 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).

Concurrently, the company added that the 2mg, single-dose, sterilized prefilled syringe provides physicians with a new way to administer EYLEA that requires fewer preparation steps compared to vials.

In addition, EYLEA is the only anti-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, said the company.

Supported by eight pivotal Phase 3 trials, the 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 in the eye by blocking VEGF-A and placental growth factor (PLGF), two growth factors involved in angiogenesis.

According to the company, EYLEA prefilled syringe is expected to be available to physicians and patients this year. 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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