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Bayer and Regeneron Extend Development Program for VEGF Trap-Eye to Include Central Retinal Vein Occlusion
Date:4/29/2009

is related to edema and the growth of abnormal new blood vessels that are mediated by vascular endothelial growth factor (VEGF), we are hopeful that VEGF Trap-Eye may help address this significant unmet medical need."

About CRVO

Over 100,000 people in the United States 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, resulting in retinal injury and loss of vision. The retina can also become "ischemic" (starved for oxygen), resulting in the growth of new abnormal blood vessels that can cause further vision loss and more serious complications. Release of VEGF contributes to increased vascular permeability in the eye and abnormal new vessel growth. It is believed that anti-VEGF treatment may help decrease vascular permeability and edema and prevent the growth of abnormal new blood vessels in the retina in patients with CRVO.

About the Phase 3 CRVO Program

In the Phase 3 CRVO program for VEGF Trap-Eye, Regeneron and Bayer HealthCare will conduct two identical multinational clinical studies: COPERNICUS (COntrolled Phase 3 Evaluation of Repeated iNtravitreal administration of VEGF Trap-Eye In Central retinal vein occlusion: Utility and Safety) will be led by Regeneron and GALILEO (General Assessment Limiting InfiLtration of Exudates in central retinal vein Occlusion with VEGF Trap-Eye) will be led by Bayer HealthCare. Enrollment will be initiated later in 2009.

Patients in both studies will receive 6 monthly intravitreal injections of either VEGF Trap-Eye at a dose of 2 milligrams (mg) or sham control injections. The primary endpoint of both studies is improvement in visual acuity versus baseline after 6 mon
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SOURCE Regeneron Pharmaceuticals, Inc.; Bayer HealthCare AG
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