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449 patients over 24 weeks. In the study, patients randomly received either injections of 0.3 mg of E10030 and 0.5 mg of ranibizumab; 1.5 mg of E10030 and 0.5 mg of ranibizumab; or 0.5 mg of ranibizumab and a placebo injection. Ophthotech reported in October that the group taking the largest dose of E10030 with Roche’s drug had better results than those taking ranibizumab alone: in the former group, patients read an average of 10.6 letters on a standardized visual acuity chart more than they had at the beginning of the study. By comparison, patients taking ranibizumab alone could read an average of 6.5 more letters than they could before—a 62 percent benefit. Ophthotech reported that it was a statistically significant improvement, meaning it was highly unlikely that the results were due to chance, and that the drug was well tolerated by patients.
Guyer says that the next study will test patients who haven’t yet been treated for wet AMD, meaning the company hopes to establish the combination regimen with any anti-VEGF as a first-line therapy for the disorder.
“We are anti-VEGF agnostic,” Guyer says. “We believe that our drug will be shown to work with any of the anti-VEGF’s.”
He added that the primary goal for the study—which is also the standard FDA regulatory endpoint for approval of such drugs—will be the same. The only difference will be that the late-stage trial will test patients over the course of a full year instead of 24 weeks.
Guyer is the co-founder and former CEO of Eyetech Pharmaceuticals, which crafted the first VEGF blocker, pegaptanib (Macugen), to be approved by the FDA for wet AMD. Eyetech had already developed what is now known as E10030 when it was acquired by OSI Pharmaceuticals for $935 million in 2005—the year before ranibizumab was approved by the FDA and stole that drug’s thunder. Guyer, who subsequently left the company to work as a partner at SV Life Sciences, licensed the newer drug from OSI in 2007 and formed Ophthotech around it with Eyetech’s other co-founder, Samir Patel (Patel is now Ophthotech’s president).
“It’s a drug we’ve known for a very long time and we’re fortunate enough to do the development on,” he says.
Guyer wouldn’t reveal how much money Ophthotech has raised to date, though he did say that Novo Ventures has been a part of the investment group since the company’s inception. Guyer added that though he believes a small company like Ophthotech can successfully sell E10030 in the U.S., the company would likely look to find a partner to help sell the drug internationally.