AR-15512 achieved statistical significance for multiple signs and symptom results in patients with dry eye disease, according to a press launch 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 deal with 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 obtain AR-15512 (0.0014%), AR-15512 (0.003%), or vehicle and were dosed twice a day over 84 days.
The study confirmed statistical significance for some symptom endpoints, including ocular discomfort at day 84 (P = .028), symptom evaluation in the dry eye at days 14, 28, and 84 (P-value between .025 and .0005), and eye dryness at day 84 (P = .03).
Moreover, the study confirmed statistical significance for several signal endpoints, together with tear production at days 1 and 14 based mostly 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).
“Whereas we didn’t obtain statistical significance at our predetermined primary endpoints at day 28, as a reminder, this is a phase 2b study where choosing main endpoints will not be required. Therefore, we believe we have a clear path towards approval,” Vicente Anido Jr., Ph.D., chairman and CEO at Aerie, said in the release. “We expect to have an end of phase 2 assembly with the U.S. Food and Drug Administration in the first quarter of 2022. As a way to complete development of AR-15512, we count on to conduct two additional 3-month phase 3 efficacy studies and a further safety study.”
Each concentration of the solution was effectively tolerated. Ninety-five percent of antagonistic occasions were gentle, and fewer than 3% of patients discontinued the trial resulting from adverse events. There were no stories of treatment-related severe or systemic adverse events.
The 0.003% concentration demonstrated the best efficacy and will be superior to phase 3 studies, the release said.