Combined therapy for AMD fails primary endpoint

A combination of Ophthotech's anti-PDGF drug pegpleranib (Fovista) and ranibizumab (Lucentis) failed to provide additional improvement in vision compared with ranibizumab alone in patients with wet AMD.

“We are very disappointed in the results from these trials, particularly for patients afflicted with wet AMD,” said David Guyer, CEO of Ophthotech.

Novartis paid Ophthotech $200 million upfront for ex-US rights to pegpleranib in 2014. Vasant Narasimhan, global head of drug development and Chief Medical Officer at Novartis, said both companies will continue to analyze the data.

"We are confident that underlying data will provide further understanding and guidance on how best to help patients with this disease,” Narasimhan said. "Novartis continues researching new treatment options for patients with nAMD, and we are looking forward to the phase III results of our next generation treatment RTH258."

The 2 clinical trials (OPH1002 and OPH1003) were international, multicenter, randomized, double-masked, controlled phase 3 studies that enrolled a total of 1,248 patients with subfoveal wet AMD. Patients treated with combined therapy gained a mean 10.24 ETDRS letters at 12 months, while patients on monotherapy gained a mean of 10.01 ETDRS letters. Even when results of the 2 trials were analyzed separately, the difference remained statistically insignificant.