Bayer, Regeneron Wet AMD Drug Shows Promise

Regeneron Pharmaceuticals, Inc. and Bayer HealthCare achieved positive results from two parallel Phase III studies in patients with the neovascular form of age-related macular degeneration (wet AMD), with all regimens of VEGF Trap-Eye (aflibercept ophthalmic solution). Both trials successfully met the primary endpoint compared to the current standard of care, ranibizumab dosed every month. The primary endpoint was statistical non-inferiority in the proportion of patients who maintained (or improved) vision over 52 weeks compared to ranibizumab.

In the North American VIEW 1 study, 96% of patients receiving VEGF Trap-Eye 0.5mg monthly, 95% receiving 2mg monthly, and 95% receiving 2mg every two months achieved maintenance of vision compared to 94% of patients receiving ranibizumab 0.5mg dosed every month. In the international VIEW 2 study, 96% of patients receiving VEGF Trap-Eye 0.5mg monthly, 96% receiving 2mg monthly, and 96% receiving 2mg every two months achieved maintenance of vision compared to 94% of patients receiving ranibizumab 0.5mg dosed every month.

In the VIEW 1 study, patients receiving VEGF Trap-Eye 2mg monthly achieved a statistically significant greater mean improvement in visual acuity at week 52 versus baseline (secondary endpoint), compared to ranibizumab 0.5mg monthly. All other dose groups of VEGF Trap-Eye in the VIEW 1 and VIEW 2 studies were not statistically different from ranibizumab in this secondary endpoint. Additionally, a generally favorable safety profile was observed for both VEGF Trap-Eye and ranibizumab.