FDA approves aflibercept injection for macular edema following central retinal vein occlusion

September 24, 2012
From staff reports
From staff reports

FDA has approved aflibercept (Eylea, Regeneron) injection for the treatment of macular edema following central retinal vein occlusion (CRVO). The recommended dose for Eylea is 2 mg every 4 weeks (monthly).

FDA has approved aflibercept (Eylea, Regeneron) injection for the treatment of macular edema following central retinal vein occlusion (CRVO). The recommended dose for Eylea is 2 mg every 4 weeks (monthly).

“This is an interesting pharmacologic product,” Formulary advisor James M. Wooten, PharmD, associate professor, department of medicine, section of clinical pharmacology, University of Missouri-Kansas City. “Aflibercept is a fusion protein that acts as a soluble decoy receptor that prevents further degeneration. It is being studied for other uses as well.”

The approval of Eylea for macular edema following CRVO was based on data from the phase 3 COPERNICUS and GALILEO studies. In both studies, the primary efficacy endpoint was the proportion of patients who gained at least 15 letters of best corrected visual acuity (BCVA) at 24 weeks compared to baseline as measured by ETDRS. Results for the Eylea 2-mg monthly group were superior to those for the sham control group for the primary end point.

"This second U.S. approval for Eylea provides physicians and patients 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 a company press release. "Based upon the pivotal phase 3 study results, Eylea has been shown to significantly improve visual outcomes in a disease characterized by high VEGF levels."

Eylea is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in Eylea.

Results from week 24 through 52 of the COPERNICUS and GALILEO studies have not yet been reviewed by FDA.