Alcon Announces Positive Topline Results From Phase 3 COMET Trials of AR-15512, a Novel Topical Drug Candidate for Dry Eye
- AR-15512, a topical transient receptor potential melastatin 8 (TRPM8) agonist, is a first-in-class product candidate for the treatment of the signs and symptoms of dry eye disease
- In both pivotal efficacy and safety studies (COMET-2 and COMET-3), the primary endpoint was achieved (p <0.0001)
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Dry eye affects an estimated 38 million people in the
U.S. and less than10% of diagnosed patients are treated with a prescription product1
Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, today announced positive topline results from the two pivotal Phase 3 clinical trials (COMET-2 and COMET-3) evaluating the efficacy and safety of AR-15512, a candidate treatment for the signs and symptoms of dry eye disease (DED).
In both COMET-2 and COMET-3, which enrolled more than 930 dry eye subjects in total (randomized 1:1 to AR-15512 or vehicle control), the primary endpoint of the proportion of subjects with at least a 10-mm increase in unanesthetized Schirmer’s score (a measure of tear production) achieved statistical significance at Day 14 [p<0.0001]. These data are consistent with the proposed mechanism of action of AR-15512.
“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,” said David Endicott, CEO of Alcon. “AR-15512 is the first product candidate in our emerging ophthalmic pharmaceutical portfolio, representing our legacy of commitment to innovation in eye care.”
AR-15512 represents an opportunity to bring relief to dry eye sufferers. While DED is one of the most common ocular disorders, affecting an estimated 38 million people in the
In these studies, additional data derived from secondary endpoints demonstrated the rapid onset and sustained tear production associated with AR-15512 compared to vehicle, as early as Day 1 and persistent to Day 90. Overall, AR-15512 was well tolerated and no serious ocular adverse events were reported.
“A key gap in dry eye medications is rapid speed of onset,” said Edward Holland, MD, Professor of Ophthalmology at the University of
AR-15512 is an investigational drug product that has not been submitted to the
Alcon's ophthalmic pharmaceutical portfolio currently includes Rocklatan®, Rhopressa®, Simbrinza®, Eysuvis®, and Inveltys®.
About Dry Eye
Dry eye disease is one of the most common ocular surface disorders, affecting an estimated 38 million adults in
About Alcon
Alcon helps people see brilliantly. As the global leader in eye care with a heritage spanning over 75 years, we offer the broadest portfolio of products to enhance sight and improve people’s lives. Our Surgical and Vision Care products touch the lives of more than 260 million people in over 140 countries each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors. Our more than 25,000 associates are enhancing the quality of life through innovative products, partnerships with Eye Care Professionals and programs that advance access to quality eye care. Learn more at www.alcon.com.
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References
- Market Scope 2023 Dry Eye Product Market Review; does not include OTC artificial tears and other Rx anti-inflammatory and tear stimulants.
- The Relationship Between Dry Eye Disease and Digital Screen Use - PMC (nih.gov)
- Improved Dry Eye Drugs for 2022 and Beyond; https://www.aao.org/eye-health/tips-prevention/new-dry-eye-treatments-ocular-surface-disease
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Source: Alcon Inc. Swiss