VEGF Trap-Eye aflibercept ophthalmic solution: Phase III data
Top-line data from the double-blind, international Phase III GALILEO trial in 172 patients with macular edema due to CRVO showed that monthly 2 mg intravitreal VEGF Trap-Eye met the primary endpoint of a significantly greater proportion of patients whose BCVA improved by >=15 letters from baseline to week 24 on the ETDRS eye chart vs. sham control (60.2% vs. 22.1%, p<0.0001). VEGF Trap-Eye also met the secondary endpoint of significantly improving BCVA as measured by mean change from baseline on the ETDRS eye chart at 24 weeks vs. sham control (18 vs. 3.3 letters gained, p<0.0001). VEGF Trap-Eye was well tolerated with a lower incidence of serious ocular adverse events compared to control (2.9% vs. 8.8%).
Patients received monthly VEGF Trap-Eye for 6 months and as needed for another 6 months. During the second 6 months, all patients were eligible for rescue laser treatment. Data will be presented at the EURETINA meeting in London this month. Last December, the partners reported data from the similar Phase III COPERNICUS trial in 187 patients showing that VEGF Trap-Eye met the same primary endpoint vs. sham control (see BioCentury, Jan. 3). Regeneron plans to submit a regulatory application in the U.S. for VEGF Trap-Eye to treat CRVO in 2H11, while partner Bayer plans to submit regulatory applications in Europe in 2012. ...