Regeneron seeks marketing clearance in EU for Eylea injection in BRVO
Regeneron Pharmaceuticals and Bayer HealthCare have applied to the European Medicines Agency to obtain marketing authorization in the European Union for Eylea in the treatment of macular edema associated with branch retinal vein occlusion, according to a press release.
The application is based on the VIBRANT trial, a phase 3 controlled, randomized study of patients with macular edema following BRVO. Results showed that 53% of patients who received monthly Eylea (aflibercept) 2 mg injections gained 15 letters, or three lines, of best corrected visual acuity from baseline to 24 weeks, compared with 27% of patients who underwent standard laser treatment (P < .001).
Patients who received aflibercept injections gained a mean 17 letters of BCVA over baseline; patients who underwent laser treatment gained a mean 6.9 letters (P < .0001).
Aflibercept was also well-tolerated; at 24 weeks, the most common adverse events were conjunctival hemorrhage and ocular pain. The incidence of serious adverse events was 9.9% in the aflibercept group and 9.8% in the control group. No cases of intraocular inflammation were reported.
The U.S. Food and Drug Administration approved aflibercept for neovascular age-related macular degeneration in November 2011 and for macular edema associated with central retinal vein occlusion in September 2012. The drug is approved in the EU and other regions for wet AMD and macular edema associated with CRVO, the release said.
Regulatory submissions for aflibercept have also been made in the U.S. for treatment of macular edema associated with BRVO, and in the U.S. and EU for treatment of diabetic macular edema, according to the release.