Alcon reports positive results from phase 3 Comet trials of AR-15512 for dry eye

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Alcon’s phase 3 Comet-2 and Comet-3 trials have met primary end points for safety and efficacy of novel topical drug candidate AR-15512 for dry eye disease (DED), the company reports. Alcon anticipates filing a new drug application (NDA) with the US FDA in mid-2024.¹

AR-15512 is a topical transient receptor potential melastatin 8 (TRPM8) agonist designed to treat the signs and symptoms of DED via increased tear production. Both Comet-2 and Comet-3 investigated efficacy measured against a primary end point of a proportion of subjects with at least a 10-mm increase in unanesthetized Schirmer score, which became statistically significant on Day 14 (P < 0.0001) and is consistent with the proposed mechanism of action of AR-15512. AR-15512 was well-tolerated by participants and no serious ocular adverse events were reported.

“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 (ECPs) and dry eye sufferers with a new and effective approach to the management of dry eye, a chronic and undertreated disease,” David Endicott, CEO of Alcon, said in a press release. “AR-15512 is the first product candidate in our emerging ophthalmic pharmaceutical portfolio, representing our legacy of commitment to innovation in eye care.”

In addition to meeting primary end points, data derived from secondary end points suggests rapid onset and sustained tear production with AR-15512 compared with vehicle. The effect appeared as early as Day 1 and continued through Day 90 in the clinical trial setting.¹

“A key gap in dry eye medications is rapid speed of onset,” said Edward Holland, MD, Professor of Ophthalmology at the University of Cincinnati, a key advisor on COMET-2 and -3 and Senior Scientific Advisor at Alcon. “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.”

DED is a continuing challenge for eye care providers, and Alcon hopes that AR-15512 will bring relief to chronic sufferers. It is estimated that 38 million people in the US are affected by dry eye, but only 18 million patients are diagnosed. Of those 18 million, only 10% are treated with a prescription product.²

At the time of reporting, AR-15512 has not been submitted to the US FDA for approval, but Alcon suggests an NDA filing will happen in mid-2024. It remains an investigational drug product that is not available for commercial use.

References

1. Alcon announces positive topline results from phase 3 COMET trials of AR-15512, a novel topical drug candidate for dry eye. Business Wire. Press release. Published January 9, 2024. Accessed January 10, 2024. https://www.businesswire.com/news/home/20240109285944/en

2. Market Scope 2023 Dry Eye Product Market Review; does not include OTC artificial tears and other Rx anti-inflammatory and tear stimulants.