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VEGF Trap-Eye Phase 2 Wet AMD Results Reported at ARVO Annual,Meeting

GF 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.

In the Phase 2 wet AMD trial, data were presented from a pre-planned interim analysis of the first 78 patients who completed 12 weeks of the study. The randomized, multi-center trial involves 150 patients who were randomized to 5 groups and treated with the VEGF Trap-Eye in one eye. Two groups received either 0.5 or 2.0 milligrams (mg) of VEGF Trap-Eye administered every 4 weeks, and three groups received a single dose of 0.5, 2.0, or 4.0 mg of VEGF Trap-Eye. Patients were monitored for safety, retinal thickness, and visual acuity over 12 weeks. The VEGF Trap-Eye met its primary endpoint of a statistically significant reduction in retinal thickness after 12 weeks compared with baseline (all groups combined, decrease of 135 microns, p less than 0.0001). Mean change in visual acuity, a key secondary endpoint of the study, also demonstrated a statistically significant improvement (all groups combined, increase of 5.9 letters, p less than 0.0001). There were no drug-related serious adverse events, and treatment with the VEGF Trap-Eye was generally well-tolerated. The most common adverse events were those typically associated with intravitreal injections. Interim data for all dose groups were presented at the ARVO meeting. The Phase 2 wet AMD study is now fully enrolled and results for all patients will be presented at a future scientific meeting.

Encouraging results were also presented from a Phase 1 study of VEGF Trap-Eye in DME. In this open-label safety study, the VEGF Trap-Eye was administered as a single 4.0 mg intravitreal injection to 5 patients with longstanding diabetes and multiple prior treatments for DME. The single injection resulted in a marked decrease in mean central retina
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