VEGF Trap-Eye Sees Positive Results in Phase 3 GALILEO Study in Patients with Macular Edema Due to CRVO
April 28, 2011
Regeneron Pharmaceuticals and Bayer HealthCare announced yesterday positive top-line results for VEGF Trap-Eye (aflibercept ophthalmic solution) in the Phase 3 GALILEO study in patients with macular edema due to central retinal vein occlusion (CRVO).
In GALILEO, the primary endpoint at week 24 was achieved: 60.2 percent of patients receiving monthly VEGF Trap-Eye 2 milligrams (mg) gained at least 15 letters of vision from baseline, compared to 22.1 percent 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).
Regeneron stated that with two Phase 3 trials now showing impressive improvement in vision relative to control, VEGF Trap-Eye has the potential to provide patients and physicians a new treatment option for central retinal vein occlusion.
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