FDA approves updated label for Regeneron’s EYLEA treating wet AMD

In a significant development for ophthalmic care, Regeneron Pharmaceuticals has received approval from the U.S. Food and Drug Administration (FDA) for a supplemental Biologics License Application (sBLA) for EYLEA (aflibercept) Injection. This approval updates the label to include a modified 12-week dosing schedule for patients with wet age-related macular degeneration (wet AMD), providing a flexible treatment regimen designed to improve patient outcomes.

The FDA’s approval of the updated label for EYLEA is based on robust data from the second year of the phase 3 VIEW 1 and 2 trials, which demonstrated the effectiveness of the 12-week dosing interval in managing wet AMD, a leading cause of vision loss among older adults. This label update will aid retinal physicians in making informed treatment decisions, offering them the flexibility to tailor dosing schedules to patient needs.

George D. Yancopoulos, President and Chief Scientific Officer at Regeneron, expressed his satisfaction with the FDA’s decision: “We are pleased that the FDA has approved an updated label for EYLEA. Providing information to retinal physicians about the visual outcomes with a modified 12-week dosing schedule will help physicians make the most informed choices in treating patients suffering from wet age-related macular degeneration.”

EYLEA is a vascular endothelial growth factor (VEGF) inhibitor that plays a crucial role in preventing the growth of new blood vessels and reducing fluid leakage in the eye. By blocking VEGF-A and placental growth factor (PLGF), EYLEA effectively manages the progression of diseases marked by unwanted angiogenesis and vascular leakage.

In the United States, EYLEA Injection is indicated not only for wet AMD but also for the treatment of Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR) in patients with DME.

The approval of the sBLA for EYLEA marks an important milestone in the treatment of ocular diseases, especially for those with wet AMD. By adapting treatment intervals based on the latest clinical evidence, Regeneron continues to pioneer advancements in therapeutic options for patients with serious eye conditions, improving both the quality of care and patient quality of life.

With this update, EYLEA sets a new standard in the personalized care approach, offering retinal specialists an enhanced tool in their arsenal against complex ocular diseases. As the prevalence of these conditions increases with an aging global population, treatments like EYLEA are critical in managing the associated vision loss effectively.