VEGF Trap-Eye: Phase III data
Top-line data from the double-blind, North American Phase III VIEW 1 trial in 1,217 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 (95.9%, 95.1% and 95.1%, respectively, vs. 94.4%). The trials' non-inferiority margin was 10%. The 2 mg every 4 weeks dose regimen of VEGF Trap-Eye also met the secondary endpoint of significantly improving visual acuity as measured by mean change from baseline on the ETDRS eye chart at week 52 (10.9 vs. 8.1 letters, p<0.01). The 0.5 mg every 4 weeks and 2 mg every 8 weeks dose regimens of VEGF Trap-Eye missed the endpoint (6.9 and 7.9 letters, respectively). 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, which have an SPA from FDA for the trial, plan to submit regulatory applications in the U.S. and Europe for the product to treat wet AMD in 1H11. ...