Ocular Therapeutix's eye drug was more effective than Eylea in a late-stage trial

Ocular Therapeutix reported that its experimental drug Axpaxli helped a higher share of patients maintain vision at 36 weeks and one year than Regeneron's Eylea in a 344-patient late-stage trial, and the company said it will discuss the data with the U.S. Food and Drug Administration.

Ocular Therapeutix said 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 reported the study enrolled 344 patients with newly diagnosed wet age-related macular degeneration. Results cited higher rates of vision maintenance at 36 weeks and at one year for Axpaxli compared with a single-dose Eylea regimen. Ocular described improved fluid control in the eye and fewer patients needing additional "rescue" injections for almost a year. Trial findings: - The trial enrolled 344 patients with newly diagnosed wet age-related macular degeneration. - At 36 weeks, about 74% of patients receiving a single 0.45 mg dose of Axpaxli maintained vision versus nearly 56% for a single 2 mg dose of Eylea. - After one year, nearly 66% of Axpaxli patients maintained vision while less than half of the comparison group did. - The company reported better fluid control in the eye with Axpaxli and said many patients did not need additional rescue injections for almost a year. - Ocular said it plans to discuss the data with the U.S. Food and Drug Administration and expects to submit a marketing application based on the results. - The article notes that Ocular's shares fell about 30% in premarket trading following the announcement. Summary: The reported results indicate higher rates of vision maintenance and improved fluid control for Axpaxli compared with Eylea in this late-stage study. Ocular Therapeutix plans to present the data to the U.S. Food and Drug Administration and expects to seek marketing authorization; regulatory review and final outcomes are undetermined at this time.