Phase 3 Study of VEGF Trap-Eye for Macular Edema
Regeneron and Bayer HealthCare announced positive results from their Phase 3 GALILEO study of VEGF Trap-Eye (aflibercept ophthalmic solution) for the treatment of patients with macular edema due to central retinal vein occlusion. A total of 104 patients were randomized to receive six monthly injections of VEGF Trap-Eye 2mg and 68 patients were randomized to receive sham injections the control group.
At Week 24, 60.2% of patients receiving monthly VEGF Trap-Eye 2mg achieved the primary endpoint, gaining at least 15 letters of vision from baseline, compared with 22.1% of patients receiving sham injections (P<0.0001). The key secondary endpoint of the study was also met: patients receiving VEGF Trap-Eye 2mg monthly gained, on average, 18 letters of vision compared to a mean gain of 3.3 letters with sham injections (P<0.0001). The GALILEO study confirmed results of the similarly designed Phase 3 COPERNICUS study that were announced in December 2010.
VEGF Trap-Eye is a fully human fusion protein, consisting of soluble VEGF receptors 1 and 2, that binds all forms of VEGF-A along with the related Placental Growth Factor (PlGF).
For more information call (877) REGN-777 or visit www.regeneron.com.