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Ophthotech has completed a multicenter, randomized, double-masked, controlled Phase 2b clinical trial evaluating the efficacy and safety of FovistaTM administered in combination with an anti-VEGF agent for the treatment of patients newly diagnosed with wet AMD. The trial included 449 patients at approximately 69 centers in North America, South America, Europe and Israel.
In this study, FovistaTM 1.5mg administered in combination with Lucentis® (ranibizumab injection) demonstrated statistically significant superiority compared to Lucentis® monotherapy based on the primary endpoint of mean change in visual acuity from baseline at 24 weeks.
Patients receiving the combination of 1.5 mg of FovistaTM and Lucentis® gained a mean of 10.6 letters from baseline on a standardized chart of vision testing compared to a mean gain of 6.5 letters from baseline for patients receiving Lucentis® monotherapy, representing a 62% comparative benefit from baseline. FovistaTM exhibited a favorable safety profile and no significant safety imbalances were observed for FovistaTM combination therapy as compared to Lucentis® monotherapy.
Based on these results, Ophthotech has initiated a pivotal Phase 3 clinical program to evaluate the safety and efficacy of FovistaTM 1.5mg in combination with anti-VEGF drugs compared to anti-VEGF monotherapy for the treatment of newly diagnosed patients with wet AMD.
Source: Ophthotech (Dec 2013)