Pegpleranib combination with Lucentis (ranibizumab) fails two Phase III trials to treat age-related macular degeneration.-Novartis + Ophthotech.

Novartis announced initial topline results from two pivotal Phase III clinical studies evaluating the safety and efficacy of pegpleranib in combination with Lucentis (ranibizumab) for the treatment of neovascular age-related macular degeneration (nAMD). Studies OPH1002 and OPH1003, sponsored by Ophthotech Corporation, did not meet the primary endpoint of superiority for the pegpleranib and ranibizumab combination therapy, measured as best corrected visual acuity (BCVA) in terms of additional letter gains over ranibizumab monotherapy.

At month 12, patients in the pegpleranib and ranibizumab combination treatment groups showed a 10.74 letter BCVA improvement in study OPH1002 and a 9.91 letter BCVA improvement in study OPH1003. Patients treated with ranibizumab alone showed a 9.82 letter BCVA improvement in the OPH1002 study and a 10.36 letter BCVA improvement in the OPH1003 study.

"The key message from the data is that the proven efficacy of Lucentis monotherapy was not improved by the addition of pegpleranib", said Vasant Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis. Data from the OPH1002 and OPH1003 studies, including secondary and exploratory efficacy endpoints, will be presented at a future medical meeting.