Phase 3 eye drug combo failure for Novartis
pharmafile | December 12, 2016 | News story | Research and Development, Sales and Marketing | Novartis, ophthotech
Novartis’ has failed in its attempt to expand the applications of its anti-VEGF eye treatment Lucentis (ranibizumab) after the drug was found to be no more effective in treating neovascular age-related macular degeneration (nAMD) when combined with Ophthotech’s anti-PDGF therapy Fovista compared to when used alone.
The primary endpoint of the two Phase 3 trials, a mean change in visual acuity at 12 months, was not achieved after observing 1,248 participants, prompting Ophthotech CEO David R. Guyer to comment: “We are very disappointed in the results from these trials, particularly for patients afflicted with wet AMD. We are thankful to the patients and clinical investigators and their staff for participating in the trials. We will continue to analyse the data from these two studies to better understand the trial results.”
Novartis signed a marketing deal worth up to $1 billion with Ophthotech for its drug Fovista in 2014.
Of the many statistics recorded comparing Lucentis as a combination treatment to Lucentis as a monotherapy, none proved statistically significant; Patients treated with Fovista and Lucentis combination therapy recorded an average increase of 10.24 letters of vision on the Early Treatment of Diabetic Retinopathy Study (ETDRS) standardised chart versus 10.1 for those treated with Lucentis as a monotherapy.
“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 of Drug Development and CMO at 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.”
It is estimated that around 25 million worldwide suffer from nAMD, the leading cause of early blindness in the modern world.
Matt Fellows
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