Novartis was denied bringing its eye drug combination of pegpleranib and Lucentis out of Phase III study for age-related vision loss.
Novartis said on Monday that 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.
The reason for a setback was that at month 12, patients in the pegpleranib and ranibizumab combination treatment groups showed a 10.74 letter BCVA improvement of vision loss deterioration 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.
“We are fully committed to innovate and grow Lucentis as standard of care in diseases of the retina and to continue our research in this area. 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 analyze 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.”
Novartis last traded at CHF 70.60, down 0.21%, at Swiss Exchange.