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VEGF Trap-Eye Submitted for EU Marketing Authorization for Treatment of Wet Age-Related Macular Degeneration
Date:6/7/2011

AMD in the U.S. in February 2011 and received a Priority Review designation.

Bayer HealthCare will market VEGF Trap-Eye outside the United States, where the companies will share equally the profits from any future sales of VEGF Trap-Eye.  Regeneron maintains exclusive rights to VEGF Trap-Eye in the United States.

About the VIEW Program

The VIEW (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD) program consists of two randomized, double-masked, Phase 3 clinical trials evaluating VEGF Trap-Eye in the treatment of the neovascular form of age-related macular degeneration (wet AMD).  The VIEW 1 study, which randomized 1,217 patients, is being conducted in the United States and Canada by Regeneron under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration.  The VIEW 2 study, which randomized 1,240 patients, is being conducted in Europe, Asia Pacific, Japan, and Latin America by Bayer HealthCare.  The study designs are essentially identical.  The primary endpoint evaluation was conducted at 52 weeks.

In each of the studies, VEGF Trap-Eye was evaluated for its effect on maintaining and improving vision when dosed as an intravitreal injection on a schedule of 0.5 mg monthly, 2 mg monthly, or 2 mg every two months (following three monthly loading doses), as compared with intravitreal ranibizumab administered 0.5 mg every month during the first year of the studies.  As-needed (PRN) dosing with both agents, with a dose administered at least every three months (but not more often than monthly) is being evaluated during the second year of each study.

About VEGF Trap-Eye

VEGF Trap-Eye is a fully human fusion protein, consisting of portions of VEGF receptors 1 and 2, that binds all forms of VEGF-A along with the related Placental Growth Factor (PlGF).  VEGF Trap-Eye is a specific and highly potent blocker of these growth factors.  VEGF Trap-Ey
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SOURCE Regeneron Pharmaceuticals, Inc.
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3. FDA Grants Priority Review for VEGF Trap-Eye for the Treatment of Wet Age-Related Macular Degeneration
4. Regeneron Submits Biologics License Application to FDA for VEGF Trap-Eye for Treatment of Wet Age-Related Macular Degeneration
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8. Enrollment Completed in Regeneron and Bayer HealthCare Phase 3 Studies of VEGF Trap-Eye in Neovascular Age-Related Macular Degeneration (Wet AMD)
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