Novartis’ macular degeneration Phase III trial did not meet endpoint
Posted: 14 December 2016 | | No comments yet
Novartis’ two pivotal Phase III clinical studies did not meet their primary endpoints to treatment of neovascular age-related macular degeneration…
Novartis‘ two pivotal Phase III clinical studies, did not meet their primary endpoints of superiority for the pegpleranib and ranibizumab combination therapy, measured as best corrected visual acuity in terms of additional letter gains over ranibizumab monotherapy, for the treatment of neovascular age-related macular degeneration (nAMD).
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.
“Together with Ophthotech we continue to analyse the data. We are confident that underlying data will provide further understanding and guidance on how best to help patients with this disease. 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.”
Data from the OPH1002 and OPH1003 studies, including secondary and exploratory efficacy endpoints, will be presented at a future medical meeting.