BioCentury
ARTICLE | Clinical News

Ophthotech's Fovista misses in third Phase III for AMD

August 18, 2017 7:49 PM UTC

Ophthotech Corp. (NASDAQ:OPHT) reported data from the double-blind, sham-controlled, international Phase III OPH1004 trial in about 640 patients with wet age-related macular degeneration (AMD) showing that intravitreal injections of 1.5 mg Fovista pegpleranib plus Eylea aflibercept or Avastin bevacizumab missed the primary endpoint of improving the mean change in visual acuity on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart from baseline to 12 months vs. Eylea or Avastin monotherapy (9.42 vs. 9.04 letters, p=0.74). The company also said the combination therapy missed the secondary endpoints, which included the proportion of patients gaining ≥20 ETDRS letters, losing ≥5 ETDRS letters and achieving visual acuity of 20/25 or better at 12 months, vs. monotherapy. Based on the data, Ophthotech said it will cease treatment of patients who are in the second year of the trial.

Last December, Fovista plus Lucentis ranibizumab missed the primary endpoint vs. Lucentis monotherapy in both the Phase III OPH1002 and OPH1003 trials to treat wet AMD (see BioCentury, Dec. 19, 2016 & Dec. 19, 2016)...