Dry eye candidate demonstrates promising results in phase 2b study
AR-15512 achieved statistical significance for multiple sign and symptom endpoints in patients with dry eye disease, according to a press release from Aerie Pharmaceuticals.
AR-15512, a TRPM8 agonist, demonstrated positive topline results in COMET-1, a phase 2b clinical study investigating the ophthalmic solution to treat dry eye disease.
COMET-1 is a randomized, double-masked, vehicle-controlled study that enrolled 369 patients across three arms. Patients were randomly assigned to receive AR-15512 (0.0014%), AR-15512 (0.003%) or vehicle and were dosed twice a day over 84 days.
The study showed statistical significance for multiple symptom endpoints, including ocular discomfort at day 84 (P = .028), symptom assessment in dry eye at days 14, 28 and 84 (P value between .025 and .0005) and eye dryness at day 84 (P = .03).
Additionally, the study showed statistical significance for multiple sign endpoints, including tear production at days 1 and 14 based on unanesthetized Schirmer’s score (P < .0001), conjunctival redness at day 84 (P = .022) and ocular surface staining at days 14 and 84 (P = .012; P = .037).
“While we did not achieve statistical significance at our predetermined primary endpoints at day 28, as a reminder, this is a phase 2b study where selecting primary endpoints are not required. Therefore, we believe we have a clear path toward approval,” Vicente Anido Jr., PhD, chairman and CEO at Aerie, said in the release. “We expect to have an end of phase 2 meeting with the U.S. Food and Drug Administration in the first quarter of 2022. In order to complete development of AR-15512, we expect to conduct two additional 3-month phase 3 efficacy studies and an additional safety study.”
Both concentrations of the solution were well tolerated. Ninety-five percent of adverse events were mild, and less than 3% of patients discontinued the trial due to adverse events. There were no reports of treatment-related serious or systemic adverse events.
The 0.003% concentration demonstrated the greatest efficacy and will be advanced to phase 3 studies, the release said.