The companies plan to initiate a Phase III program evaluating the efficacy and safety of VEGF Trap-Eye in the treatment of central retinal vein occlusion (CRVO) in the second half of 2009. The Phase III program in CRVO will consist of two, multinational, one-year clinical studies which have been reviewed with regulatory authorities.
In the Phase III CRVO program for VEGF Trap-Eye, Regeneron and Bayer HealthCare will conduct two identical multinational clinical studies: Copernicus will be led by Regeneron and Galileo will be led by Bayer HealthCare. Enrollment will be initiated later in 2009.
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). Enrollment in the wet AMD and DME studies is expected to be completed later in 2009.
Patients in both studies will receive six monthly intravitreal injections of either VEGF Trap-Eye at a dose of 2mg or sham control injections. The primary endpoint of both studies is improvement in visual acuity versus baseline after six months of treatment. At the end of the initial six months, all patients will be dosed on a PRN (as needed) basis for another six months. All patients will be eligible for rescue laser treatment.
Kemal Malik, head of global development and member of the Bayer HealthCare executive committee, said: “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.
“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.”