VEGF Trap-Eye: Phase III data
Top-line data from the double-blind, international Phase III VIEW 2 trial in 1,240 patients showed that 0.5 mg intravitreal VEGF Trap-Eye every 4 weeks or 2 mg VEGF Trap-Eye every 4 or 8 weeks met the primary endpoint of non-inferiority to 0.5 mg Lucentis ranibizumab every 4 weeks in the proportion of patients who maintained or improved vision from baseline to week 52 (96.3%, 95.6% and 95.6%, respectively, vs. 94.4%). The trials' non-inferiority margin was 10%. All dose regimens of VEGF Trap-Eye missed the secondary endpoint of significantly improving visual acuity as measured by mean change from baseline on the ETDRS eye chart at week 52 vs. Lucentis (9.7, 7.6 and 8.9 letters, respectively, vs. 9.4 letters). The most common ocular adverse events were conjunctival hemorrhage, macular degeneration, eye pain, retinal hemorrhage and vitreous floaters. Patients will continue to receive 0.5 or 2 mg VEGF Trap-Eye every 3 months for an additional 52 weeks. The partners plan to submit regulatory applications in the U.S. and Europe for the product to treat wet AMD in 1H11. ...