Ophthotech Corporation today announced results from the first clinical
trial to show statistically significant superior efficacy over Lucentis®
(ranibizumab) monotherapy for the treatment of neovascular age-related
macular degeneration (wet AMD).
In a prospective, randomized, controlled Phase 2b clinical trial of 449 patients with wet AMD, Ophthotech’s FovistaTM anti-PDGF therapy (1.5 mg), administered in combination with Lucentis anti-VEGF therapy, met the pre-specified primary efficacy endpoint of mean vision gain. Patients receiving the combination of Fovista (1.5 mg) and Lucentis gained a mean of 10.6 letters of vision on the ETDRS standardized chart at 24 weeks, compared to 6.5 letters for patients receiving Lucentis monotherapy (p=0.019), representing a 62% additional benefit.
No significant safety issues were observed for either treatment group in
Enhanced visual outcomes of Fovista anti-PDGF (1.5 mg) combination
therapy as compared to Lucentis monotherapy were demonstrated at every
monthly timepoint. In addition, the relative magnitude of visual benefit
continued to increase over time. The visual benefit of anti-PDGF (1.5
mg) combination therapy compared to Lucentis monotherapy was greater at
the 6-month timepoint than at the 3-month timepoint. The increasing
divergence of the efficacy curves suggests the benefit of chronic
anti-PDGF combination therapy. A classic dose-response curve was
"This is a truly remarkable finding for patients with wet AMD. To
achieve a 62% relative visual benefit over anti-VEGF monotherapy is
extraordinary," commented retina specialist Carmen A. Puliafito, M.D.,
Dean of the Keck School of Medicine at the University of Southern
California. "The very compelling and robust results of this
well-executed study validate PDGF as an important target for wet AMD and
set the stage for a new era of combination therapy via co-formulation or
fixed-combination delivery. I look forward to the rapid development of
this important drug for our patients."