FDA approves Regeneron’s Eylea for CRVO

Regeneron announced via press release that the U.S. Food and Drug Administration has approved Eylea intravitreal injection for macular edema after central retinal vein occlusion.

This is the FDA’s second approved indication for Eylea (aflibercept). The drug was approved for intravitreal injection for the treatment of neovascular age-related macular degeneration in November 2011. Aflibercept consists of portions of human VEGF receptors 1 and 2 and is formulated as an iso-osmotic solution for intravitreal injection, according to the press release.

“This second U.S. approval for Eylea provides physicians with a new treatment option for the treatment of macular edema following CRVO,” George D. Yancopoulos, MD, PhD, chief scientific officer of Regeneron and president of Regeneron Laboratories, said in the press release.

The approval was based on phase 3 data from the COPERNICUS and GALILEO studies. The recommended dose for patients is 2 mg administered every 4 weeks, according to the release.

According to company materials, macular edema following central retinal vein occlusion affects eight in 10,000 Americans. It occurs mostly in patients older than 50 years with hypertension or diabetes.

This article first appeared on Healio.com on September 21, 2012.
Read the full article here: Healio.com: FDA approves Regeneron’s Eylea for CRVO