Regeneron, Bayer HealthCare Initiate Phase III Program for VEGF Trap-Eye
Regeneron Pharmaceuticals and Bayer HealthCare AG announced the start of a Phase III study of the VEGF Trap-Eye in the neovascular form of age-related macular degeneration (wet AMD).
According to Regeneron and Bayer HealthCare, the study will be a noninferiority comparison of the VEGF Trap-Eye and ranibizumab (Lucentis), an anti-angiogenic agent approved for use in wet AMD.
The trial, known as VIEW 1 (VEGF Trap: Investigation of Efficacy and safety in wet age-related macular degeneration), is the first study in the companies’ Phase III global development program, which the companies said they plan to carry out in the U.S., Europe and other parts of the world.
According to the companies, the randomized, double-masked Phase III study 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 and 2.0 mg administered at four-week dosing intervals and 2.0 mg at an eight-week dosing interval, compared with 0.5 mg of ranibizumab administered every four weeks, the companies said.
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 with ranibizumab patients, the companies said.
After the first year of treatment, patients will continue to be treated and followed for another year, the companies added.