Anti-PDGF, anti-VEGF combination demonstrates superior efficacy for wet AMD

Princeton, NJ-Results from a phase IIb, prospective, randomized, double-masked clinical trial of treatment for neovascular age-related macular degeneration (AMD) show significantly better improvement in visual acuity among patients receiving combination therapy with Fovista (formerly known as E10030, Ophthotech), an investigational pegylated aptamer directed against platelet-derived growth factor subunit B (PDGF-B), plus ranibizumab (Lucentis, Genentech) compared with a parallel control group receiving ranibizumab alone.

The study enrolled 449 patients with subfoveal neovascular AMD and randomly assigned them into three arms to receive monthly intravitreal injections of ranibizumab 0.5 mg plus Fovista 0.3 mg, ranibizumab 0.5 mg plus Fovista 1.5 mg, or ranibizumab 0.5 mg plus sham. Mean gain in ETDRS visual acuity at week 24 was assessed as the primary efficacy endpoint.

The results showed a dose-response benefit for Fovista and statistically significant superiority comparing the combination of Fovista 1.5 mg and ranibizumab versus sham plus ranibizumab. Mean gain in ETDRS visual acuity was 10.6 letters for patients treated with the higher dose of Fovista in combination with ranibizumab and 6.5 letters for controls receiving ranibizumab monotherapy (p = 0.019).

Visual acuity data from earlier visits showed better outcomes in the group receiving Fovista 1.5 mg plus ranibizumab compared with the patients who received ranibizumab monotherapy at all monthly intervals, and the magnitude of the difference between groups increased with time, suggesting a benefit of continuing combination therapy with the anti-PDGF and anti-vascular endothelial growth factor agents. There were no significant safety issues identified during the 6 months of follow-up.

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