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Ophthotech’s wet-AMD drug Fovista fails in phase 3 AMD trial

PBR Staff Writer Published 15 August 2017

Ophthotech’s anti-PDGF therapy Fovista (pegpleranib) for treating wet age-related macular degeneration (AMD) has failed to meet the primary endpoint in a phase 3 trial.

The trial dubbed as OPH1004 had investigated the superiority of Fovista in combination with Eylea (aflibercept) or Avastin (bevacizumab) anti-VEGF therapy over Eylea or Avastin monotherapy. It was held in about 640 patients having wet AMD.

However, the Fovista combination could not meet the primary endpoint which was pre-specified to be the mean change in visual acuity at 12 months.

Ophthotech reported that the pre-specified primary efficacy analysis did not yield statistically significant results.

Also, it did not find any visual benefit to be clinically meaningful in the pre-specified secondary endpoints as well among the patient arm that was treated with Fovista in combination with Eylea or Avastin regimen.

The safety profile of Fovista combination therapy was found to be on par with what was observed in the previous studies, stated Ophthotech.

As a result of the findings from the OPH1004 study, the American biopharmaceutical company had suspended treating patients who had entered in the second year of the phase 3 clinical trial.

Ophthotech CEO and president Glenn P. Sblendorio said: “We express our sincere appreciation to the patients and clinical investigators and their staffs for their dedication to completing this third Phase 3 clinical trial of Fovista in combination with anti-VEGF therapy.

“This outcome does not affect our strategy as the Company moves forward with multiple ongoing or planned clinical programs in orphan retinal diseases coupled with multiple ongoing or planned clinical trials in back of the eye indications.”

In December last year, Ophthotech had reported that two of its pivotal phase 3 trials OPH1002 and OPH1003 in wet AMD patients could not establish superiority of Fovista therapy in combination with Lucentis (ranibizumab) anti-VEGF therapy compared to Lucentis monotherapy.


Image: Ophthotech’s Fovista fails to meet primary endpoint in a phase 3 wet AMD trial. Photo: courtesy of jk1991 / FreeDigitalPhotos.net.