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Positive Interim Phase 2 Data Reported for VEGF Trap-Eye in,Age-Related Macular Degeneration

the lives of patients suffering from wet AMD, which accounts for 90% of AMD related blindness," said Kemal Malik, M.D., member of the Bayer HealthCare Executive Committee, responsible for Global Development. "These results encourage us in our plans to foster next steps in development and to further study the VEGF Trap-Eye in additional eye diseases."

Based on these results, Regeneron and Bayer HealthCare AG plan to initiate the VEGF Trap-Eye Phase 3 program in the second half of 2007. The companies are collaborating on the global development of the VEGF Trap-Eye for the treatment of wet AMD, diabetic eye diseases, and other eye diseases and disorders. Bayer HealthCare AG and Regeneron will jointly commercialize the VEGF Trap-Eye outside the United States, and Regeneron maintains exclusive rights in the United States.

The Phase 2 study is a 12-week, multi-center trial involving 150 patients who are randomized to 5 groups and treated with the VEGF Trap-Eye in one eye. Two groups received either 0.5 or 2.0 mg of VEGF Trap-Eye administered every four weeks, and three groups received a single dose of 0.5, 2.0, or 4.0 mg of VEGF Trap-Eye. Patients are monitored for safety, retinal thickness, and visual acuity over 12 weeks. Retinal thickness is determined by optical coherence tomography (OCT) scans read at an independent reading center. Visual acuity is defined as the total number of letters read correctly on the Early Diabetic Retinopathy Study (ETDRS) chart. Maintenance of vision is defined as losing fewer than 3 lines (equivalent to 15 letters) on the ETDRS chart.

The interim analysis was conducted on the first 78 patients who completed 12 weeks of study. As summarized above, overall, patients had a statistically significant improvement in retinal thickness and visual acuity. All but one patient maintained or improved vision at 12 weeks. Although the improvement in visual acuity was numerically larger in patients receiving injections every 4 weeks
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