Ophthotech reports Phase III trials of Fovista to treat wet AMD fail to meet primary endpoint
US-based biopharmaceutical company Ophthotech has reported that its two pivotal Phase III clinical trials of Fovista (pegpleranib) failed to meet its pre-specified primary endpoint while treating wet age-related macular degeneration (AMD).
US-based biopharmaceutical company Ophthotech has reported that its two pivotal Phase III clinical trials of Fovista (pegpleranib) failed to meet its pre-specified primary endpoint while treating wet age-related macular degeneration (AMD).
Fovista has been developed to target platelet derived growth factor (PDGF) and in combination with anti-VEGF drugs to prevent formation of abnormal new blood vessels in wet AMD.
It inhibits PDGF from binding to its natural receptor on pericytes, thereby separating pericytes from newly formed abnormal blood vessels.
OPH1002 and OPH1003 were the two international, multicentre, randomised, double-masked, controlled Phase III trials, which intended to determine the safety and efficacy of 1.5mg of Fovista in combination with Lucentis compared with Lucentis monotherapy.
Both trials enrolled 1,248 patients with wet AMD who were randomised to one of two approximately equal-sized treatment groups.
"We are very disappointed in the results from these trials, particularly for patients afflicted with wet AMD."
The combined analysis of both trials suggested no significant difference in achieving letters of vision on the Early Treatment of Diabetic Retinopathy Study (ETDRS) standardised chart between the patient group receiving a Fovista and Lucentis combination and the other patient group receiving Lucentis monotherapy.
Additionally, a pooled analysis of both the trials suggested 13.5% of patients receiving Fovista and Lucentis combination achieved visual acuity of 20/25 compared to 13.9% of patients receiving Lucentis monotherapy.
Ophthotech CEO David Guyer said: "We are very disappointed in the results from these trials, particularly for patients afflicted with wet AMD.
"We are thankful to the patients and clinical investigators and their staff for participating in the trials. We will continue to analyse the data from these two studies to better understand the trial results."
Both the Fovista combination therapy and Lucentis monotherapy were generally well tolerated, with ocular adverse events mostly observed in the Fovista combination therapy compared to the Lucentis monotherapy group.