Industry News — Clinical Updates
Fovista Phase 2b Data Show Reduction in Subretinal Fibrosis Using Fovista Combination Therapy vs Anti-VEGF Monotherapy
Phase 2b trial subgroup analysis comparing Fovista (anti-PDGF, Ophthotech Corporation, New York, New York) (1.5 mg) combination therapy with Lucentis (ranibizumab, Genentech, Inc, South San Francisco, CA) (0.5 mg) vs Lucentis (0.5 mg) alone demonstrated a reduction of subretinal fibrosis in wet-AMD patients in the combination therapy group vs Lucentis monotherapy.
The purpose of the retrospective analysis was to assess the evolution and severity of subretinal fibrosis in eyes with visual loss (n = 70) treated with either combination Fovista (1.5 mg) and Lucentis (0.5 mg) or monotherapy Lucentis (0.5 mg). Certified and independent readers masked to drug and treatment regimen assessed the evolution and/or progression of fibrosis, and retinal images were graded on a 0 to 4 categorical scale of increasing severity of subretinal fibrosis.
The mean change in severity of subretinal fibrosis from baseline to the conclusion of the study at 24 weeks was 0.97 vs 2.0 (P = .003), favoring the combination therapy group. At 24 weeks, approximately twice the number of patients (54%) in the monotherapy group were noted to have progression of subretinal fibrosis compared to the combination therapy group (27%). In eyes without any subretinal fibrosis at baseline, subretinal fibrosis developed in 10% of patients in the combination therapy group compared to 51% in the monotherapy group.
The Fovista Phase 3 program consists of 3 clinical trials to evaluate the safety and efficacy of Fovista in combination with anti-VEGF drugs for the treatment of wet AMD. Ophthotech plans to enroll approximately 1866 patients in more than 225 centers worldwide and expects to release initial Phase 3 topline data in 2016.
Updated: September 16, 2014