Regeneron secures updated label approval from FDA for EYLEA in wet-AMD

August 19, 2018 | Filed under: Pharma Regulatory News | Posted by: pharmanewsdaily Tags: Aflibercept, EYLEA, George D. Yancopoulos, Regeneron Pharmaceuticals, US FDA, USA, Wet age-related macular degeneration

The US Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) by Regeneron Pharmaceuticals for EYLEA (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD).

Regeneron Pharmaceuticals said that the sBLA is supported by second-year data recorded from the phase 3 VIEW 1 and 2 trials in which patients with wet AMD were treated with a modified 12-week dosing schedule. The company said that the data has now been added in the updated EYLEA label.

George D. Yancopoulos – President and Chief Scientific Officer of Regeneron said: “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 physicans make the most informed choices in treating patients suffering from wet age-related macular degeneration.”

EYLEA has also been given approval in wet AMD for every four- or eight-week dosing intervals following three initial monthly doses.

FDA approves EYLEA SBLA in wet-AMD. Photo courtesy of pakize öztürk/Freeimages.com

According to Regeneron Pharmaceuticals, EYLEA is a vascular endothelial growth factor (VEGF) inhibitor, which has been designed to prevent the growth of new blood vessels and reduce the ability of fluid to pass via blood vessels in the eye by preventing VEGF-A and placental growth factor (PLGF), which are two growth factors involved in angiogenesis.

In the US, EYLEA Injection is indicated for treating patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema after Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR) in DME patients.