Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Bayer HealthCare today announced that Bayer HealthCare has submitted an application to the European Medicines Agency (EMA) seeking marketing authorization in the European Union (EU) for EYLEA® (aflibercept) Injection for the treatment of macular edema following branch retinal vein occlusion (BRVO).
The EMA submission is based on the positive Phase 3 VIBRANT trial, a double-masked, randomized, active-controlled study of patients with macular edema following BRVO. In the VIBRANT study, 53 percent of patients who received EYLEA 2 milligram (mg) monthly gained at least 15 letters (equivalent to three lines) in best-corrected visual acuity (BCVA) from baseline at week 24, the primary endpoint of the study, compared to 27 percent of patients who received laser, a standard of care (p < 0.001) treatment. In addition, EYLEA met a key secondary endpoint, achieving a 17.0 letter mean improvement over baseline in BCVA compared to a 6.9 letter mean improvement in patients who received laser (p < 0.0001).
EYLEA was generally well tolerated in this trial. Through week 24, the most common ocular adverse events in patients treated with EYLEA were conjunctival hemorrhage and eye pain. The incidence of serious adverse events (SAE) was 9.9 percent in the EYLEA group and 9.8 percent in the laser group. Up to week 24, one death and one Anti-Platelet Trialists' Collaboration (APTC) defined event (non-fatal stroke) occurred during the trial, both events occurred in patients in the laser group. There were no cases of intraocular inflammation. There was one ocular SAE in a patient in the EYLEA group, which was a traumatic cataract.
EYLEA was approved in the United States for the treatment of neovascular (wet) Age-related Macular Degeneration (AMD) in November 2011 and for Macular Edema following Central Retinal Vein Occlusion (CRVO) in September 2012. EYLEA has also been approved in the EU and other countries for use in wet AMD and Macular Edema following CRVO.
Regulatory submissions have also been made in the U.S. for EYLEA for the treatment of macula edema following BRVO, and in the U.S and EU for the treatment of Diabetic Macular Edema (DME).
Bayer HealthCare and Regeneron are collaborating on the global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States. Bayer HealthCare licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of EYLEA, except for Japan where Regeneron receives a percentage of net sales.
Regeneron Pharmaceuticals, Inc.