Ocular Therapeutix's eye drug shows benefit over Eylea in late-stage trial

Ocular Therapeutix reported that its experimental drug Axpaxli helped more patients maintain vision than Regeneron's Eylea in a 344-patient late-stage trial, and the company said it will discuss the data with the U.S. FDA and expects to submit a marketing application.

Ocular Therapeutix reported that its experimental drug Axpaxli was more effective than Regeneron's approved treatment Eylea at helping patients maintain vision in a late-stage trial. The company said this is the first investigational drug for wet age-related macular degeneration to show better results than an approved treatment in a trial meeting strict U.S. Food and Drug Administration standards. The firm described the disorder as causing blurred vision or blind spots and said it affects about 1.7 million Americans. The trial enrolled 344 newly diagnosed patients and compared single doses of Axpaxli and Eylea. Key trial findings: - The trial enrolled 344 patients with newly diagnosed wet age-related macular degeneration. - About 74% of patients given a single 0.45 mg dose of Axpaxli maintained vision at 36 weeks, compared with nearly 56% given a single 2 mg dose of Eylea. - After one year, nearly 66% of Axpaxli patients maintained vision, while less than half in the comparison group did. - Axpaxli also demonstrated better fluid control in the eye, and many patients did not need additional "rescue" injections for almost a year. - The article mentions a higher incidence of vitreous floaters and cataracts and a Needham analyst noting a narrower difference between the drugs. - The article mentions Ocular plans to discuss the data with the U.S. Food and Drug Administration and expects to submit a marketing application based on the results. Summary: The trial reported that Axpaxli outperformed Eylea on measures of maintained vision and fluid control in this late-stage study. Ocular Therapeutix plans to engage with the U.S. FDA and expects to submit a marketing application; other regulatory and safety reviews are pending. Market reaction included a noted premarket decline in Ocular Therapeutix shares.