Regeneron Pharmaceuticals and Bayer HealthCare AG initiated a Phase III study of the VEGF Trap-Eye in the neovascular form of age-related macular degeneration (wet AMD). The study will compare the VEGF Trap-Eye and ranibizumab, Genentech's Lucentis, an anti-angiogenic agent approved for wet AMD. The study will be conducted for the FDA's Special Protocol Assessment (SPA).
The VIEW 1 trial is expected to enroll approximately 1,200 patients in more than 200 centers throughout the U.S. and Canada. The study will evaluate the safety and efficacy of the VEGF Trap-Eye at doses of 0.5 mg and 2.0 mg administered at four-week dosing intervals and 2.0 mg at an eight-week dosing interval, compared to 0.5 mg of Lucentis administered every four weeks.
The primary endpoint of the study is the proportion of patients treated with the VEGF Trap-Eye who maintain or improve vision at the end of one year, compared to Lucentis patients. After the first year of treatment, patients will continue to be treated and followed for another year.
Interim data from the ongoing Phase II trial in wet AMD demonstrated a statistically significant reduction in retinal thickness and improvement in visual acuity after 12 weeks, compared to baseline. There were no drug-related serious adverse events, and treatment with the VEGF Trap-Eye was generally well tolerated.
The two companies are collaborating on the global development of the wet AMD treatment, diabetic eye diseases, and other eye diseases and disorders. Bayer HealthCare will market the VEGF Trap-Eye outside the U.S. and Regeneron maintains exclusive rights to the VEGF Trap-Eye in the U.S.