FDA Approves Eylea Injection sBLA

Regeneron Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Eylea (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD). The sBLA was based on second-year data from the Phase 3 VIEW 1 and 2 trials in which patients with wet AMD were treated with a modified 12-week dosing schedule (doses given at least every 12 weeks, and additional doses as needed). These data are now included in the updated Eylea label.

"We are pleased that the FDA has approved an updated label for Eylea," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. "Providing information to retinal physicians about the visual outcomes with a modified 12-week dosing schedule will help physicans make the most informed choices in treating patients suffering from wet age-related macular degeneration."

Eylea is also approved in wet AMD for every four- or eight-week dosing intervals after three initial monthly doses.

Eylea 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 seven pivotal Phase 3 trials.

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