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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)
Date:12/20/2010

60;There were six deaths (3.4%) among the 175 patients treated with VEGF Trap-Eye and one (2.3%) in the 44 patients treated with laser over 12 months.

Detailed results for DA VINCI will be presented at the Angiogenesis Conference in Miami, Florida in February 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 identical GALILEO (General Assessment Limiting Infiltration of Exudates in central retinal vein Occlusion with VEGF Trap-Eye) studies receive six monthly injections of either VEGF Trap-Eye at a dose of 2mg or sham injections.  Patients in the COPERNICUS trial were randomized in a 3:2 ratio with 114 patients randomized to receive VEGF Trap-Eye and 73 randomized to the control arm.  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 are 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 was 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.  

About Central Retinal Vein Occlusion (CRVO)Over 100,000 people in the United States and more than 66,000 people in key European countries are estimated to suffer from CRVO.  CRVO is caused by obstruction of the central retinal vein that leads to a back up of blood and fluid in the retina.  This causes retinal injury and loss of vision.  The retina can also become "ischemic" (starved for oxygen), resulting in the growth of new
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SOURCE Regeneron Pharmaceuticals, Inc.
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1. Bayer and Regeneron Dose First Patient in Second Phase 3 Study for VEGF Trap-Eye in Wet Age-Related Macular Degeneration
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3. 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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