Aerie Pharmaceuticals has announced the dosing of the first participant in the Phase III clinical trial of AR-15512 ophthalmic solution to treat dry eye disease (DED).
The registrational COMET-2 trial will evaluate the solution as a treatment for DED signs and symptoms.
The randomised, vehicle-controlled, double-masked, multi-centre trial is the first of three trials in the Phase III AR-15512 registrational programme.
The other two trials are expected to be initiated by Aerie in the second half of this year to support the filing of a potential New Drug Application (NDA) in 2024.
Expected to enrol around 460 participants at 20 centres in the US, COMET-2 will assess the safety and efficacy of the TRPM8 agonist AR-15512 in DED patients.
Participants in the trial will be given the AR-15512 (0.003%) or AR-15512 vehicle as a drop dosed two times a day in each eye for a period of three months.
Tear production is the primary efficacy assessment, as measured by the unanesthetized Schirmer test (sign), and the key secondary measure is symptoms of dry eye based on the Symptom Assessment iN Dry Eye (SANDE) questionnaire.
Throughout the trial, subjects will be evaluated on multiple efficacy and safety assessments at several timepoints.
The company expects topline results from the COMET-2 study in the second half of next year.
Aerie Pharmaceuticals Clinical Development and Medical Affairs head Michelle Senchyna said: “This study builds on the results of the COMET-1 study which showed statistically significant, dose-dependent improvements on multiple validated sign, symptom, and quality of life endpoints across multiple timepoints.”
“There is a significant unmet need for an effective treatment that can provide a rapid and robust onset of efficacy, and meaningful relief of dry eye symptoms. AR-15512 has the potential to be the new standard of care for patients suffering from dry eye disease.”
In October last year, Aerie reported positive data from the Phase III clinical trial of netarsudil ophthalmic solution 0.02% to treat open-angle glaucoma and elevated intraocular pressure (IOP), in Japan.