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Enrollment Completed in Regeneron and Bayer HealthCare Phase 3 Studies of VEGF Trap-Eye in Neovascular Age-Related Macular Degeneration (Wet AMD)
Date:9/14/2009

AMD, vision is not improved or stabilized in all patients despite monthly office visits and examinations that are inconvenient for these often elderly patients," said George D. Yancopoulos, M.D., Ph.D., President of Regeneron Research Laboratories. "This Phase 3 program is exploring various doses and dosing schedules with our novel anti-VEGF investigational agent to evaluate whether further improvements in vision and/or longer dosing intervals than monthly administration are possible."

About the VIEW Program

The VIEW 1 study is being conducted in the United States and Canada by Regeneron and the VIEW 2 study is being conducted in Europe, Asia Pacific, Japan, and Latin America by Bayer HealthCare. In the first year of the studies, the safety and efficacy of VEGF Trap-Eye at doses of 0.5 mg and 2.0 mg administered at four-week intervals and 2.0 mg at an eight-week dosing interval following one additional 2.0 mg dose at week four are being evaluated. Patients randomized to the ranibizumab arm of the trial will receive a 0.5 mg dose every four weeks. After the first year of treatment, patients will continue to be followed and treated for another year on a flexible, criteria-based extended PRN regimen with a dose administered at least every 12 weeks, but not more often than every four weeks until the end of the study.

The primary endpoint of these non-inferiority studies is the proportion of patients treated with VEGF Trap-Eye who maintain vision at the end of one year, compared to ranibizumab patients. Visual acuity is defined as the total number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart, a standard chart used in research to measure visual acuity. Maintenance of vision is defined as losing fewer than three lines (equivalent to 15 letters) on the ETDRS chart. Key secondary endpoints include the mean change from baseline in visual acuity as measured by ETDRS and
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SOURCE Regeneron Pharmaceuticals, Inc.
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