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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

disease.  The incidence of ocular serious adverse events was higher in the sham group compared to the active treatment arm (8.8% vs 2.9%).

Regeneron intends to submit a regulatory application for marketing approval in CRVO in the U.S. in the second half of 2011, and Bayer HealthCare is planning to submit regulatory applications in Europe in 2012.

Detailed results of the GALILEO study will be presented at the EURETINA Congress in London in May, 2011.

About the Phase 3 CRVO Program

Patients in the COPERNICUS (Controlled Phase 3 Evaluation of Repeated intravitreal administration of VEGF Trap-Eye In Central retinal vein occlusion: Utility and Safety) and the almost identical GALILEO (General Assessment Limiting Infiltration of Exudates in central retinal vein Occlusion with VEGF Trap-Eye) studies received six monthly injections of either VEGF Trap-Eye at a dose of 2mg or sham injections.

Patients in both trials were randomized in a 3:2 ratio with 114 patients randomized to receive VEGF Trap-Eye and 73 randomized to the control arm in COPERNICUS and 104 patients randomized to receive VEGF Trap-Eye and 68 randomized to the control arm in GALILEO.  At the end of the initial six months, all patients randomized to VEGF Trap-Eye are dosed on a PRN (as needed) basis for another six months.  In the COPERNICUS trial, patients randomized to sham injections in the first six months were eligible to cross over to VEGF Trap-Eye PRN dosing in the second six months.  During the second six months of the studies, all patients are eligible for rescue laser treatment.  Visual acuity is measured as a score based on the total number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart, a standard chart used in research to measure visual acuity.

Phase 3 GALILEO Study Results

In the GALILEO study, 60.2 percent of patients receiving VEGF Trap-Eye 2mg monthly gained
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SOURCE Regeneron Pharmaceuticals, Inc.
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9. Regeneron and Bayer Report Positive Results for VEGF Trap-Eye in Phase 3 Study in Central Retinal Vein Occlusion (CRVO) and in Phase 2 Study in Diabetic Macular Edema (DME)
10. Regeneron Schedules December 20, 2010 Teleconference and Webcast to Discuss Results of VEGF Trap-Eye Phase 3 Study in Central Retinal Vein Occlusion (CRVO) and Phase 2 Study in Diabetic Macular Edema (DME)
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