Aerie Pharmaceuticals has announced positive top-line data from the Phase IIb COMET-1 clinical trial of the AR-15512 ophthalmic solution to treat dry eye disease.
AR-15512, a TRPM8 agonist, was observed to improve various symptoms and signs of the disease.
The randomised, double-masked, vehicle-controlled COMET-1 trial was performed at 15 sites across the US in a total of 369 patients to assess the therapeutic’s safety and efficacy.
Participants were given the AR-15512 (0.0014%), AR-15512 (0.003%) or AR-15512 vehicles twice a day for 84 days and were analysed on days 1, 14, 28 and 84.
Trial data revealed the highest efficacy with the higher 0.003% concentration twice daily and this dose will progress to Phase III trials.
The Phase IIb trial demonstrated statistical significance on several pre-specified symptom endpoints, including ocular discomfort and dryness of eye at day 84, and Symptom Assessment in Dry Eye (SANDE) at days 14, 28 and 84.
Statistical significance was also reported for various pre-specified sign endpoints, with efficacy seen following the first dose.
The improved sign endpoints included tear production at days 1 and 14, conjunctival redness at day 84 and ocular surface staining at days 14 and 84.
Aerie added that the statistically significant improvements in symptoms as well as signs were demonstrated at day 14 and continued through day 84.
Both AR-15512 formulations were found to be safe and well-tolerated, with 95% of adverse events being mild.
Aerie Pharmaceuticals chairman and CEO Vicente Anido said: “While we did not achieve statistical significance at our pre-determined primary endpoints at day 28, as a reminder, this is a Phase IIb study where selecting primary endpoints are not required. Therefore, we believe we have a clear path toward approval.
“We expect to have an end of Phase II meeting with the US Food and Drug Administration in the first quarter of 2022.”
The company plans to further assess AR-15512 in two three-month Phase III efficacy studies and one safety study.