The COMET-2 study is the first of three studies in the AR-15512 phase 3 registration program, with topline results expected by the second half of 2023.
Aerie Pharmaceuticals announced Tuesday that the first participant has been dosed in the phase 3 registrational “COMET-2” study evaluating AR-15512 ophthalmic solution for the treatment of dry eye disease (DED).
As the first of three trials in the phase 3 registrational program for AR-15512, COMET-2 is a randomized, double-masked, vehicle-controlled, multi-center clinical study analyzing the safety of AR-15512 in patients diagnosed with DED, according to a news release.
AR-15512 acts as a cold thermoreceptor modulator to stimulate cold-sensing receptors located on the nerve endings that innervate the cornea and eyelids, according to Aerie.
By stimulating these receptors, the first-in-class TRPM8 agonist then leads to natural tear production and a cooling sensation across the eye surface—resulting in a reduction of DED symptoms.
The COMET-2 study is expected to enroll an estimated 460 participants at 20 sites across the US. Patients will receive AR-15512 (0.003%) or AR-15512 vehicle as a drop dosed twice a day in each eye for 3 months, according to the release.
Primary efficacy assessment is tear production, which will be measured by the unanesthetized Schirmer test (sign). The key secondary measure is DED symptoms that are based on the Symptom Assessment iN Dry Eye (SANDE) questionnaire, the company reported. Additionally, patients will be evaluated on multiple efficacy and safety assessments at numerous timepoints during the study.
“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,” stated Michele Senchyna, PhD, head of clinical development and medical affairs at Aerie, in the release.
The AR-15512 phase 3 registration program also includes two other studies: COMET-3 (an efficacy studies, as is the COMET-2 study), and the COMET-4 safety study. COMET-3—identical to COMET-2— is expected to commence patient enrollment in the third quarter of 2022, with topline results expected to be available by the second half of 2023, the release stated.
COMET-4 is planned to begin in the fourth quarter of 2022 as a 12-month safety study. The release also stated that Aerie intends to incorporate interim 6-month data from the COMET-4 study into the New Drug Application (NDA) filing for AR-15512, slated to be submitted in 2024.
Topline results from the COMET-2 study are expected to be released in the second half of 2023.