Alcon’s investigational drops shows promising Phase III data in dry eye disease

Alcon’s investigational drops shows promising Phase III data in dry eye disease

Published: Jan 10, 2024

By Tristan Manalac

BioSpace

Alcon on Tuesday posted promising top-line results from two pivotal Phase III clinical trials—COMET-2 and COMET-3—demonstrating that its investigational eye drops AR-15512 improved tear production in patients with dry eye disease.

The Swiss eye disease specialist did not reveal specific data in its news release, but said that in both studies, AR-15512 treatment led to a higher proportion of patients achieving at least a 10-mm improvement in unanesthetized Schirmer’s score, a validated measure of tear production. At day 14, this effect reached statistical significance, with a p-value less than 0.0001, according to Alcon’s announcement.

As for safety, Alcon also reported that AR-15512 was well-tolerated. There were no serious ocular adverse events documented in COMET-2 or COMET-3.

In a statement, Alcon CEO David Endicott said that Tuesday’s readouts underscore AR-15512’s “potential to address the limitations of current dry eye prescription options,” providing both doctors and patients with a new approach to treat the chronic condition.

Data from both studies also showed that AR-15512 met its secondary endpoints, eliciting rapid-onset and durable tear production as compared with vehicle controls. This benefit was apparent as early as day 1 and persisted through 90 days of observation.

“A key gap in dry eye medications is rapid speed of onset,” Edward Holland, professor of ophthalmology at the University of Cincinnati, said in Alcon’s announcement. “AR-15512 demonstrated this important achievement in both pivotal efficacy and safety studies and it represents a first-in-class candidate for chronic dry eye.” Holland is a scientific advisor at Alcon and is a key advisor on COMET-2 and COMET-3.

Armed with these data, Alcon expects to submit a New Drug Application to the FDA by mid-2024, according to its news release.

AR-15512 is a topical, first-in-class agonist of the TRPM8 receptor, which is a cold-sensing channel found in the dorsal root and trigeminal ganglia. AR-15512 stimulates cold-sensing receptors in nerves that innervate the cornea and eyelids, thereby inducing a cooling sensation across the eye and stimulating natural tear production.

The candidate was first discovered and developed by Aerie Pharmaceuticals, which Alcon bought for $770 million in August 2022.

Tuesday’s positive readout from COMET-2 and COMET-3 comes after a high-profile rejection in the dry eye disease space.

In November 2023, the FDA denied approval for Aldeyra Therapeutics’ investigational reactive aldehyde species modulator reproxalap, which the company was hoping to position as a treatment for dry eye disease. In the Complete Response Letter, the agency pointed to a lack of data to establish the candidate’s efficacy in treating dry eye symptoms and asked for at least one more well-controlled trial.

Source: BioSpace