Promising Phase III Results for Alcon's Dry Eye Drops

Swiss pharmaceutical company Alcon has announced positive results from two Phase III clinical trials, COMET-2 and COMET-3, for its experimental eye drops, AR-15512, which are designed to treat dry eye syndrome. The trials showed that the treatment significantly increased tear production in affected patients. Although specific data were not disclosed, Alcon indicated that a greater number of participants saw at least a 10-mm improvement in their Schirmer’s score, a standard measure for tear production, by day 14, with a statistically significant p-value of less than 0.0001.

The trials also indicated that AR-15512 was well-tolerated by patients, with no serious ocular adverse events reported. Alcon's CEO, David Endicott, highlighted the potential of AR-15512 to offer a new treatment option for dry eye disease, which could overcome the limitations of current prescription treatments. The trials' data revealed that AR-15512 not only had a rapid onset of action but also provided sustained tear production, with benefits observed from day one through to the 90-day observation period.

According to Edward Holland, an ophthalmology professor at the University of Cincinnati and a scientific advisor at Alcon, the rapid onset of AR-15512 is a significant advantage in the treatment of dry eye disease. He noted that AR-15512 is a first-in-class candidate for chronic dry eye treatment. Alcon plans to submit a New Drug Application to the FDA by mid-2024.

AR-15512 is a novel topical treatment that acts as an agonist of the TRPM8 receptor, a cold-sensing channel present in certain nerve ganglia. By stimulating these receptors, AR-15512 induces a cooling sensation in the eye and promotes natural tear production. The drug was originally discovered and developed by Aerie Pharmaceuticals, which Alcon acquired in August 2022 for $770 million.

The positive results from the COMET-2 and COMET-3 trials are particularly noteworthy following the FDA's rejection of Aldeyra Therapeutics' dry eye treatment, reproxalap, in November 2023. The FDA requested additional well-controlled trials to establish the efficacy of reproxalap in treating dry eye symptoms. Alcon's AR-15512, therefore, represents a promising development in the ongoing search for effective treatments for dry eye disease.