Fovista: Phase IIb data

A double-blind, U.S. Phase IIb trial in 449 patients with neovascular wet AMD showed that once-monthly 1.5 mg/eye intravitreal Fovista plus Lucentis ranibizumab met the primary endpoint of improving mean visual acuity as measured by the ETDRS eye chart from baseline to week 24 vs. Lucentis alone (10.6 vs. 6.5 letters gained, p=0.019). Additionally, high-dose Fovista plus Lucentis led to an average absolute improvement in visual acuity from baseline of 7.4% compared to Lucentis alone in all patients who gained 1-5 ETDRS lines of vision. High-dose Fovista plus Lucentis also improved visual acuity from baseline relative to Lucentis alone by 25% in patients who gained >=3 ETDRS lines of vision, by 69% in patients who gained >=4 lines and by 178% in patients who gained >=5 lines. Data for the 0.3 mg/eye dose of Fovista were not disclosed. No significant safety issues were reported in either treatment group. Patients received 0.3 or 1.5 mg/eye intravitreal Fovista plus Lucentis or Lucentis alone every 4 weeks for 24 weeks. Ophthotech plans to start Phase III testing of Fovista, but did not disclose details. ...