Bayer HealthCare, Regeneron to initiate new clinical program for VEGF Trap-Eye in CRVO

TARRYTOWN, N.Y. — Bayer HealthCare and Regeneron Pharmaceuticals have extended their VEGF Trap-Eye development partnership to include a new phase 3 program designed to evaluate the safety and efficacy of the agent for treating patients with central retinal vein occlusion, according to a joint press release from the companies.

Expected to begin later this year, the phase 3 program will consist of two identical multinational 1-year clinical trials. The first, called 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; Bayer will spearhead the second trial, called GALILEO (General assessment limiting infiltration of exudates in central retinal vein occlusion with VEGF Trap-Eye).

In both studies, patients will receive six monthly injections of either 2-mg doses of VEGF Trap-Eye or sham injection. The primary endpoint of both studies will be visual acuity improvement after 6 months of treatment. Once the primary endpoint is reached, dosing will be continued on an as-needed basis for an additional 6 months, according to the release.

All patients will be eligible for rescue laser treatment.

Currently, Bayer and Regeneron's global development collaboration for VEGF Trap-Eye includes two ongoing phase 3 studies in patients with neovascular age-related macular degeneration and a phase 2 study for treating diabetic macular edema.

Enrollment in these studies is expected to conclude later this year.