Novartis' plans to develop a combination of Lucentis with pegpleranib to treat patients with neovascular age-related macular degeneration (nAMD) have suffered a setback after it failed to induce better outcomes than Lucentis alone in late-stage studies.
Two pivotal Phase III studies - OPH1002 and OPH1003 - did not show additional improvement in best corrected visual acuity (BCVA) for pegpleranib and Lucentis (ranibizumab) combination therapy over Lucentis monotherapy, the current standard of care.
At month 12, patients in the pegpleranib and Lucentis combination treatment groups showed a 10.74 letter BCVA improvement in study OPH1002 and a 9.91 letter BCVA improvement in study OPH1003, while those given Lucentis alone showed a 9.82 and a 10.36 letter improvement, respectively.
"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 of Drug Development and Novartis' chief medical officer.
"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."
Age-related macular degeneration (AMD) is a common and degenerative eye condition caused by damage to the macula, affecting around 20 to 25 million people worldwide. nAMD occurs when abnormal blood vessels form underneath the macula and cause damage to the cells, particularly if they leak blood and fluid into the eye. Left untreated, vision deteriorates within days.
In May 2014, Novartis signed a license and commercialisation deal with Ophthotech, which left it with exclusive rights to pegpleranib outside the US, where Ophthotech holds the rights.
Data from the OPH1002 and OPH1003 studies, including secondary and exploratory efficacy endpoints, will be presented at a future medical meeting, Novartis said.