Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive topline results for EYLEA® (aflibercept) Injection from the Phase 3 VIBRANT study in patients with Macular Edema following Branch Retinal Vein Occlusion (BRVO). In this trial, 53% of patients who received EYLEA 2 milligram (mg) every four weeks gained at least 15 letters in vision from baseline at week 24, the primary endpoint of the study, compared to 27% of patients who received laser, a standard-of-care treatment (p<0.001). Patients who received EYLEA 2 mg every four weeks achieved a 17.0 letter mean improvement over baseline in best corrected visual acuity (BCVA) compared to a 6.9 letter mean improvement in patients who received laser (p<0.0001), a key secondary endpoint. VIBRANT is the first Phase 3 trial in this indication in which an anti-VEGF agent was directly compared to an active comparator.
The incidence of serious adverse events (SAE) was 9.9% in the EYLEA group and 9.8% in the laser group. One death and one Anti-Platelet Trialists' Collaboration (APTC) defined event (non-fatal stroke) occurred during the trial, both in patients in the laser group. The most common ocular adverse events in the EYLEA treated patients were conjunctival hemorrhage and eye pain. There were no cases of intraocular inflammation. There was one ocular SAE in a patient in the EYLEA group, which was a traumatic cataract.
"These positive data in patients with macular edema following BRVO further support the efficacy of EYLEA in a broad spectrum of retinal diseases," stated George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. "If approved, we hope to be able to offer physicians and patients a new treatment option for addressing macular edema associated with this severe and potentially blinding retinal disorder."
"VIBRANT represents the eighth positive trial from the EYLEA Phase 3 program, which has enrolled over 3,800 patients from around the world and highlights our commitment to retinal diseases," said Robert Vitti, M.D., Vice President, Clinical Sciences, Ophthalmology, Regeneron Pharmaceuticals. "We want to thank all the investigators and patients involved in this study. We are proud of the effort consistently put forth by the EYLEA development team."
Detailed results from this study will be presented at an upcoming medical conference. Regeneron intends to submit a regulatory application for marketing approval for macular edema following BRVO in the U.S. within the next several months.
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 Europe, Japan, Australia, and in many other countries for use in wet AMD and in Europe and other countries for Macular Edema following CRVO.
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 royalty on net sales.
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