This new approval was based on results from two randomized, multi-center, double-masked, sham-controlled studies Phase 3 studies called COPERNICUS and GALILEO. The study evaluated a total of 358 patients for the safety and efficacy of Eylea 2mg monthly vs. placebo. In both studies, the primary efficacy endpoint was the proportion of patients who gained at least 15 letters of Best Corrected Visual Acuity (BCVA) at 24 weeks compared to baseline as measured by ETDRS. Results for the EYLEA 2mg monthly group gained at least 15 letters of Best Corrected Visual Acuity (BCVA) from baseline, as measured by ETDRS, compared to 12% of patients receiving sham injections (p<0.01), the primary endpoint of the study. Results from week 24–52 of the COPERNICUS and GALILEO studies have not yet been reviewed by the FDA.
Eylea is a recombinant fusion protein consisting of a human VEGF inhibitor and human IgG1. It is already indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD).
For more information call (914) 345-7400 or visit www.eylea.com.