Regeneron Completes Enrollment In Two Phase 3 Studies For wet AMD

Regeneron has completed patient enrollment in two randomised, double-masked, phase 3 clinical trials evaluating VEGF Trap-Eye in the treatment of the neovascular form of age-related macular degeneration (wet AMD).

VEGF Trap-Eye, an investigational drug, is being developed by Regeneron and Bayer HealthCare for the potential treatment of eye diseases, including wet AMD, diabetic macular edema (DME), and Central Retinal Vein Occlusion (CRVO).

Reportedly, in each study of the VIEW (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD) program, VEGF Trap-Eye is being evaluated for its effect on maintaining and improving vision when dosed as an intravitreal injection on a schedule of 0.5mg every four weeks, 2.0mg every four weeks, or 2.0mg every eight weeks, as compared with intravitreal ranibizumab administered 0.5mg every four weeks during the first year of the studies.

Each study has enrolled in excess of the targeted 1,200 patient goal. One-year primary endpoint data from both studies are expected in the fourth quarter of 2010. These studies are part of the global development program for VEGF Trap-Eye being conducted by Regeneron and Bayer HealthCare.

George Yancopoulos, president of Regeneron Research Laboratories, said: “Even with recent advances in the treatment of wet AMD, vision is not improved or stabilised in all patients despite monthly office visits and examinations that are inconvenient for these often elderly patients. This phase 3 program is exploring various doses and dosing schedules with our novel anti-VEGF investigational agent to evaluate whether further improvements in vision and/or longer dosing intervals than monthly administration are possible.”