Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) and Bayer HealthCare announced positive top-line results for VEGF Trap-Eye (aflibercept ophthalmic solution) in the COPERNICUS study, which is led by Regeneron, the first of two Phase 3 studies in patients with macular edema due to central retinal vein occlusion (CRVO). In this trial, 56.1 percent of patients receiving VEGF Trap-Eye 2 milligrams (mg) monthly gained at least 15 letters of vision from baseline, compared to 12.3 percent of patients receiving sham injections (p<0.0001), the primary endpoint of the study. Patients receiving VEGF Trap-Eye 2mg monthly gained, on average, 17.3 letters of vision compared to a mean loss of 4.0 letters with sham injections (p<0.001), a secondary endpoint. The second Phase 3 study, GALILEO, is currently ongoing and is led by Bayer HealthCare.
VEGF Trap-Eye was generally well tolerated and the most common adverse events were those typically associated with intravitreal injections or the underlying disease. A total of 114 patients were randomized to receive VEGF Trap-Eye and 73 patients to the control arm. Serious ocular adverse events in the VEGF Trap-Eye group were uncommon (3.5%) and were more frequent in the control group (13.5%). The incidence of non-ocular serious adverse events was generally well-balanced between the treatment arms. There were no deaths among the 114 patients treated with VEGF Trap-Eye and two in the 73 (2.7%) patients treated with sham injections.
"In the COPERNICUS trial, patients treated with VEGF Trap-Eye experienced a marked improvement in vision," said George D. Yancopoulos, M.D., Ph.D., President of Regeneron Research Laboratories. "If these results are confirmed by data from the GALILEO study, expected in the second quarter of 2011, VEGF Trap-Eye could provide patients and physicians with a new treatment option for central retinal vein occlusion."
"After reporting positive results from our global Phase 3 program (VIEW 1 and VIEW 2 studies) for the treatment of the neovascular form of age related macular degeneration (wet AMD), we are pleased to also have a positive Phase 3 trial with VEGF Trap-Eye in central retinal vein occlusion, a potential second indication," said Kemal Malik, MD, Head of Global Development and member of the Bayer HealthCare Executive Committee. "We are working diligently with Regeneron to prepare regulatory filings for VEGF Trap-Eye in wet AMD to submit in the first half of 2011."
Detailed results for COPERNICUS will be presented at the Angiogenesis Conference in Miami, Florida in February 2011.
Regeneron will receive a $10 million milestone payment from Bayer HealthCare in connection with the COPERNICUS trial meeting its primary endpoint and received a $10 million milestone payment in December 2010 for the positive VIEW 1 and VIEW 2 trial results in wet AMD.