Ophthotech Plunges as Wet AMD Drug Combo Trials With Novartis AG Flops in Phase III Studies
December 12, 2016
By Alex Keown, BioSpace.com Breaking News Staff
BASEL, Switzerland – The fortunes of Novartis -backed Ophthotech Corporation have plunged as the Swiss company announced two Phase III clinical trials combining Fovista and Lucentis to treat neovascular age-related macular degeneration failed to meet primary endpoints.
Novartis and Ophthotech struck a deal to combine drug treatments for AMD in 2014 in a bid to bolster its eye-drug portfolio.
Ophthotech stock is down more than 84 percent this morning, plunging from Friday’s close of $38.77 per share to $5.93 per share this morning. Shares of Novartis also took a bit of a hit, but nowhere near the drop of Ophthotech. Shares of Novartis are down to $69.26 this morning.
Novartis has been looking for something to bolster sales of Lucentis, which fell 11 percent in the first three quarters of 2016 outside the United States, Reuters reported. That loss was on top of sales’ declines in 2015 as Novartis has been facing increased competition from other drugs, including Regeneron’s Elyea. Age-related macular degeneration impacts an estimated 20 to 25 million people worldwide.
Novartis, which licensed the AMD drug in 2014 from New York-based Ophthotech, announced the trials evaluating pegpleranib in combination with the company’s Lucentis (ranibizumab) failed to meet the primary endpoint of superiority for the pegpleranib and ranibizumab combination therapy. The endpoints measured as best corrected visual acuity (BCVA) in terms of additional letter gains over ranibizumab monotherapy.
The company said patients treated in one of the combination trials actually fared worse than patients treated with Lucentis alone. The primary efficacy endpoint in both studies was defined as mean change in best corrected visual acuity (BCVA) from baseline at 12 months. A number of secondary and exploratory efficacy endpoints are currently being analyzed across both studies.
The company said after 12 months, patients in the pegpleranib and ranibizumab combination treatment groups showed a 10.74 letter BCVA improvement. Patients treated with Lucentis (ranibizumab) alone showed a 9.82 letter BCVA improvement, the company said.
"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", Vasant Narasimhan, global head of drug development and chief medical officer at Novartis, said in a statement. "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 said data from the two studies, OPH1002 and OPH1003, including secondary and exploratory efficacy endpoints, will be presented at a future medical meeting.
Novartis has another trial to treat nAMD in its pipeline. Data from that trial is expected early next year, Reuters said.