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The novel topical dry eye disease candidate achieved a statistically significant ≥10-mm increase in unanesthetized Schirmer’s score at Day 14.
Positive topline results from the phase 3 COMET-2 and COMET-3 trials showed that AR-15512, a novel topic drug candidate, achieved its primary endpoint as a treatment for the signs and symptoms of dry eye disease (DED).1
Announced by Alcon on January 9, 2024, the pivotal efficacy and safety studies enrolled more than 930 patients with DED to be treated with the first-in-class topical transient receptor potential melastatin 8 (TRPM8) agonist or placebo. The primary endpoint of an increase in tear production measures was achieved across both studies (P <.0001).
An investigational drug product, AR-15512 has not been submitted for approval to the US Food and Drug Administration and is not commercially available. Alcon has indicates its plan to file the New Drug Application (NDA) for AR-15512 in mid-2024.
“A key gap in dry eye medications is rapid speed of onset,” Edward Holland, MD, a professor of ophthalmology at the University of Cincinnati, and senior scientific advisor at Alcon, said in a statement.1 “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.”
Approximately 38 million people in the United States are affected by DED, making it one of the most common ocular disorders.2 However, data have shown only around 18 million are diagnosed, with ≤10% treated with a prescription product. Alcon indicated that AR-15512 may represent a chance to provide relief to people with dry eyes, particularly a chronic treatment that can provide rapid natural tear production.1
Across COMET-2 and COMET-3, patients with DED were randomized 1:1 to AR-15512 or vehicle control. The primary endpoint consisted of the proportion of individuals with ≥10-mm increase in unanesthetized Schirmer’s score across both trials. Analyses showed the primary endpoint achieved statistical significance at Day 14 (P <.001) – Alcon indicated these data are consistent with the proposed mechanism of action of AR-15512.
Secondary endpoints obtained from the trials exhibited the rapid onset and sustained tear production associated with AR-15512 compared to vehicle, as early as Day 1 and remained until Day 90. Safety analyses indicated AR-15512 was overall well-tolerated and the trials reported no serious ocular adverse events.
“We are excited by AR-15512 as it has the potential to address the limitations of current dry eye prescription options and provide eye care professionals and dry eye sufferers with a new and effective approach to the management of dry eye, a chronic and undertreated disease,” David Endicott, the chief executive officer of Alcon, said in a statement.1 “AR-15512 is the first product candidate in our emerging ophthalmic pharmaceutical portfolio, representing our legacy of commitment to innovation in eye care.
In November 2022, Alcon completed an acquisition of Aerie Pharmaceuticals, Inc. and acquired a pipeline of ophthalmic pharmaceutical product candidates.3 The acquisition included the commercial products netarsudil and latanoprost ophthalmic solution 0.02%/0.005% (Rocklatan) and netarsudil ophthalmic solution (Rhopressa), as well as AR-15512.