Aramis Biosciences Completes Enrollment of its Phase 2 Clinical Trial Evaluating A197 for the Treatment of Dry Eye Disease

Aramis Biosciences announced the completion of enrollment in its phase 2 proof of concept clinical trial evaluating A197, a novel, first-in-class, topical immunomodulatory agent for the treatment of dry eye disease.

“We are very pleased to have completed the enrollment of our phase 2 study for A197 and look forward to topline data by the end of the first quarter of 2023,” said David S. Tierney, MD, Aramis Biosciences’ President and CEO. “We would like to thank the patients who enrolled in the study as well as the clinical investigators and other research staff who have worked diligently to get us to this point.”

About A197-CS-201

The phase 2, multicenter, double-masked, randomized, vehicle-controlled, parallel-group clinical trial (NCT05238597) is designed to evaluate the safety and tolerability as well as explore the efficacy of two doses of A197 ophthalmic solution in 207 patients with dry eye disease. The primary endpoint of the trial measures the change from baseline in corneal fluorescein staining with a key secondary endpoint evaluating eye dryness symptoms using the visual analog scale (VAS). The clinical trial is being conducted across 24 centers in the United States.