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GEN News Highlights : Apr 30, 2009

Bayer and Regeneron Expand Development Program for VEGF Trap-Eye

Firms will begin Phase III testing in central retinal vein occlusion in the second half of this year.

Bayer HealthCare and Regeneron Pharmaceuticals are extending their global development program for Regeneron’s VEGF Trap-Eye to include central retinal vein occlusion (CRVO). The companies plan to initiate a Phase III study in the second half of this year.

The program will consist of two, multinational, one-year clinical studies, which have been reviewed with regulatory authorities. The companies' partnership already includes two Phase III studies in patients with the wet age-related macular degeneration (AMD) and a Phase II trial in diabetic macular edema (DME). Enrollment in the wet AMD and DME studies is expected to be completed later this year.

"Although CRVO is a leading cause of blindness, there is currently no treatment available that can be universally considered to be the standard of care, and there is no approved treatment to prevent the loss of vision or improve vision once it is lost," said Dr. Kemal Malik, head of global development and member of the Bayer HealthCare Executive Committee. "Since the underlying biology of CRVO 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."