Topline proof-of-concept data are expected by the first quarter of 2023.
Aramis Biosciences announced Monday that the first patient has been dosed in its phase 2 trial analyzing A197, a novel first-in-class, topical immunomodulatory agent, for the treatment of dry eye disease (DED).
The phase 2, multi-center, double-masked, randomized, vehicle-controlled clinical trial (NCT05238597) is evaluating the safety and tolerability of A197.
Two doses of A197 ophthalmic solution will be distributed in approximately 200 patients diagnosed with DED, according to a company news release.
Primary endpoints are measuring the change from baseline in corneal fluorescein staining. A key secondary endpoint is evaluating eye dryness symptoms using the visual analog scale.
An estimated 20 centers across the United States will participate in the trial.
Topline proof-of-concept data is expected by the first quarter of 2023, according to David S. Tierney, MD, Aramis Biosciences’ president and CEO.