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# Ophthotech Eye Drug Fails Phase 3 Trials
- URL: https://www.fdaweb.com/ophthotech-eye-drug-fails-phase-3-trials/
- Published: 2016-12-12T12:00:00.000Z
- Updated: 2026-09-14T21:53:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137540

Ophthotech says two Phase 3 studies evaluating its wet age-related macular degeneration (AMD) drug Fovista (pegpleranib) failed to meet the pre-specified primary endpoint of mean change in visual acuity at 12 months. The studies are evaluating Fovista in combination with Lucentis (ranibizumab) compared to Lucentis monotherapy. The two clinical trials (OPH1002 and OPH1003) were international, multicenter, randomized, double-masked, controlled Phase 3 studies that enrolled 1,248 patients with wet AMD. The results from the databases of the two trials were unmasked and analyzed concurrently, according to the company.

  
“Based on a preliminary analysis of the safety data from these two trials, Fovista combination therapy and Lucentis monotherapy were generally well tolerated after one year of treatment,” Ophthotech says. “The ocular adverse events more frequently reported in the Fovista combination therapy group compared to the Lucentis monotherapy group were mainly related to the injection procedure. The incidence of reported serious systemic adverse events was generally similar in both treatment groups as was the incidence of myocardial infarction or cerebrovascular accident.”