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Regeneron and Bayer Report Positive Results for VEGF Trap-Eye in Second Phase 3 Study in Central Retinal Vein Occlusion
Date:4/27/2011

TARRYTOWN, N.Y. and BERLIN, April 27, 2011 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Bayer HealthCare today announced positive top-line results for VEGF Trap-Eye (aflibercept ophthalmic solution) in the Phase 3 GALILEO study in patients with macular edema due to central retinal vein occlusion (CRVO).  The positive results from the GALILEO study confirm the results of the similarly designed Phase 3 COPERNICUS study that were announced in December 2010.

In GALILEO, the primary endpoint at week 24 was achieved: 60.2 percent of patients receiving monthly VEGF Trap-Eye 2 milligrams (mg) gained at least 15 letters of vision from baseline, compared to 22.1 percent of patients receiving sham injections (p<0.0001).  The key secondary endpoint of the study was also met: patients receiving VEGF Trap-Eye 2mg monthly gained, on average, 18 letters of vision compared to a mean gain of 3.3 letters with sham injections (p<0.0001).

"After reporting positive results from the VIEW 1 and VIEW 2 Phase 3 studies for the treatment of the neovascular form of age-related macular degeneration, or wet AMD, we are very pleased to now also have two positive Phase 3 trials with VEGF Trap-Eye in central retinal vein occlusion," said Kemal Malik, M.D., Head of Global Development and member of the Bayer HealthCare Executive Committee.

"With two Phase 3 trials showing impressive improvement in vision relative to control, VEGF Trap-Eye has the potential to provide patients and physicians a new treatment option for central retinal vein occlusion," said George D. Yancopoulos, M.D., Ph.D., President of Regeneron Research Laboratories.

As in the COPERNICUS trial, VEGF Trap-Eye was generally well tolerated in the GALILEO study and the most common adverse events were those typically associated with intravitreal injections or the underlying
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SOURCE Regeneron Pharmaceuticals, Inc.
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