Bayer and Regeneron Extend Development Program for VEGF Trap-Eye to Include Central Retinal Vein...( Two Phase 3 studies to start in the s...),Health

Two Phase 3 studies to start in the second half of this year

BERLIN and TARRYTOWN, N.Y., April 30 /PRNewswire-FirstCall/ -- Bayer HealthCare AG and Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today announced that the companies are extending their global development program for VEGF Trap-Eye, an investigational agent for the treatment of certain eye diseases, to include Central Retinal Vein Occlusion (CRVO). The companies plan to initiate a Phase 3 program evaluating the efficacy and safety of VEGF Trap-Eye in the treatment of CRVO in the second half of this year. CRVO is caused by obstruction of the central retinal vein that 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 abnormal new blood vessels that can cause further vision loss and more serious complications.

The Phase 3 program in CRVO will consist of two, multinational, one-year clinical studies which have been reviewed with regulatory authorities. These studies will expand the companies' global development collaboration for VEGF Trap-Eye, which already includes two ongoing Phase 3 studies in patients with the neovascular form of Age-related Macular Degeneration (wet AMD) and a Phase 2 study in patients with 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
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