Regeneron submits VEGF Trap-Eye BLA to FDA for treatment of wet AMD
January 27, 2016
The VEGF Trap-Eye BLA is based on the positive results from two Phase 3 trials, the North American VIEW 1 trial and the global VIEW 2 trial. In these trials, all regimens of VEGF Trap-Eye, including VEGF Trap-Eye dosed 2 milligrams (mg) every two months (following three loading doses), successfully met the primary endpoint of non-inferiority, compared to the current standard of care, ranibizumab 0.5 mg dosed every month. The primary endpoint analysis was statistical non-inferiority in the proportion of patients who maintained (or improved) vision over 52 weeks compared to ranibizumab. A generally favorable safety profile was observed for both VEGF Trap-Eye and ranibizumab. The ocular adverse events were balanced across all treatment groups in both studies. There were no notable differences in non-ocular adverse events among the study arms.
SOURCE Regeneron Pharmaceuticals, Inc.