Bayer HealthCare AG and Regeneron Pharmaceuticals would extend their development programme for VEGF Trap-Eye, an investigational new substance for the treatment of certain eye diseases, to include Central Retinal Vein Occlusion (CRVO).
The companies plan to initiate a phase-III programme evaluating the efficacy and safety of VEGF Trap-Eye in the treatment of this disease in the second half of this year. CRVO is caused by obstruction of the central retinal vein that leads to retinal injury and loss of vision. The retina can also become 'ischemic' (starved for oxygen), resulting in the growth of new, inappropriate blood vessels that can cause further vision loss and more serious complications.
The phase-III programme in CRVO will consist of two, multinational, one year clinical studies which have been reviewed with US and European regulatory authorities. These studies will expand the companies' global development collaboration for VEGF Trap-Eye, which already includes two ongoing phase-III studies in patients with the neovascular form of Age-related Macular Degeneration (wet AMD) and a phase-II study in patients with Diabetic Macular Edema (DME). Enrolment in the 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 worldwide that can be considered 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 inappropriate growth of new blood vessels that are mediated by vascular endothelial growth factor, we are hopeful that VEGF Trap-Eye may help address this significant unmet medical need."
Over 100,000 people in the United States and more than 66,000 people in key European countries are estimated to suffer from CRVO.
Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body whose normal role is to trigger formation of new blood vessels (angiogenesis) to support the growth of the body's tissues and organs.
Regeneron is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of serious medical conditions.