Regeneron announced that the FDA has approved Eylea (aflibercept injection) for the treatment of neovascular (wet) age-related macular degeneration (AMD). The approval of Eylea was granted under Priority Review of two Phase 3, randomized, multicenter, double-masked, active-controlled studies. In these studies, Eylea dosed every eight weeks, following three initial monthly injections, was clinically equivalent to the standard of care, Lucentis (ranibizumab injection; Genentech) dosed every four weeks, as measured by the primary endpoint of maintenance of visual acuity (less than 15 letters of vision loss on an eye chart) over 52 weeks.
Eylea will be available soon in single eye-use vials containing aflibercept 40mg/mL solution for intravitreal injection.
For more information call (914) 345-7400 or visit www.regeneron.com.