FEB 25, 2014
Comprehensive Ophthalmology, Retina/Vitreous
Regeneron Pharmaceuticals announced that the U.S. FDA has accepted for standard review a supplemental Biologics License Application for Eylea (aflibercept) for macular edema following branch retinal vein occlusion (BRVO). A decision is expected within the next 10 months.
Eylea is approved for wet AMD and for macular edema following central retinal vein occlusion in the United States, the European Union (EU) and other countries. Regulatory submissions have been made in the United States and the EU to also include an indication for diabetic macular edema.
The application for Eylea is based on positive results from the phase 3 VIBRANT trial, a double-masked, randomized, active-controlled study of 183 patients with macular edema following BRVO. Patients received either intravitreal Eylea 2 mg every four weeks or laser treatment for 24 weeks. The primary objective of the study, which is ongoing through week 52, is to evaluate the efficacy and safety of Eylea in improving best-corrected visual acuity compared to laser treatment at week 24.