Axpaxli shows modest advantage over Eylea in trial
Retinal specialists may value trial data more than investors, analyst says
Ocular plans FDA discussions and marketing application
Updates share movement, details and background throughout
By Kamal Choudhury
Feb 17 (Reuters) - Ocular Therapeutix's OCUL.O experimental eye drug showed superiority to Regeneron's REGN.O Eylea in a key late-stage trial, but its modest advantage and higher rates of certain side effects sent shares tumbling about 30% on Tuesday.
The Massachusetts-based company said the drug, Axpaxli, is the first investigational treatment for wet age-related macular degeneration to show better results than an approved treatment in a trial meeting strict FDA standards.
The chronic eye disorder, a leading cause of blindness among the elderly, causes blurred vision or a blind spot in the patient's visual field.
The trial enrolled 344 patients with newly diagnosed wet AMD and showed that about 74% of patients who received a single 0.45 mg dose of Axpaxli maintained their vision at 36 weeks, compared with nearly 56% of those receiving 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.
Jones Trading analyst Debanjana Chatterjee said that while the trial achieved statistical significance, the 18-percentage-point difference at week 36 fell well short of the expected 50-point gap and below the 30- to 40-point benchmark anticipated by the investors.
Needham analyst Serge Belanger said while results "allow Ocular to seek a superiority label", investors are disappointed by the "much narrower difference" between the drugs and the higher incidence of vitreous floaters and cataracts.
Safety data showed higher rates of eye‑related side effects with Axpaxli, with 52.9% of patients reporting issues compared with 33.7% on Eylea.
"Retinal specialists are likely to appreciate today's data better than investors," Belanger added.
The company 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.
(Reporting by Kamal Choudhury in Bengaluru; Editing by Vijay Kishore)
((Kamal.Choudhury@thomsonreuters.com;))