Ophthotech Corporation announced that the pre-specified primary endpoint of mean change in visual acuity at 12 months was not achieved in its Phase 3 clinical trial investigating the superiority of Fovista (pegpleranib) anti-PDGF therapy in combination with Eylea (aflibercept) or Avastin (bevacizumab) anti-VEGF therapy compared to Eylea or Avastin monotherapy for the treatment of wet age-related macular degeneration (AMD). The addition of 1.5mg of Fovista to an Eylea or Avastin regimen did not result in benefit as measured by the mean change in visual acuity at the 12-month time point.
“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,” said Glenn P. Sblendorio, Chief Executive Officer and President of Ophthotech. “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.”
This clinical trial (also known as OPH1004) was an international, multicenter, randomized, double-masked, controlled Phase 3 study. In the OPH1004 trial, subjects receiving Fovista in combination with Eylea or Avastin therapy gained a mean of 9.42 letters of vision on the ETDRS standardized chart at 12 months, compared to a mean gain of 9.04 ETDRS letters in patients receiving Eylea or Avastin monotherapy, a resulting difference of 0.38 ETDRS letters (p=0.74). The results for the pre-specified primary efficacy analysis were not statistically significant. In addition, the Company did not observe any clinically meaningful visual benefit in the pre-specified secondary endpoints when Fovista was added to Eylea or Avastin regimen. Based on these data, the Company has decided to stop treating patients who are in the second year of the OPH1004 study. The Phase 3 trial enrolled approximately 640 patients with wet AMD.
Based on a preliminary analysis of the safety data from the trial, Fovista® combination therapy and Eylea® or Avastin®monotherapy were generally well tolerated after one year of treatment. The ocular adverse events more frequently reported in the Fovista® combination therapy group compared to the Eylea® or Avastin® monotherapy group were mainly related to the injection procedure. The safety profile of Fovista® combination therapy remains unchanged from prior trials.
In December 2016, Ophthotech announced that the pre-specified primary endpoint of mean change in visual acuity at 12 months was not achieved in its two pivotal Phase 3 clinical trials (also known as OPH1002 and OPH1003) investigating the superiority of Fovista® therapy in combination with Lucentis® (ranibizumab) anti-VEGF therapy compared to Lucentis® monotherapy for the treatment of wet AMD. The addition of Fovista® to a monthly Lucentis® regimen did not result in benefit as measured by the mean change in visual acuity at the 12-month time point.
Filed Under: Drug Discovery
