Alcon Reports Positive Phase 3 COMET Trial Results for Dry Eye Drug AR-15512

AR-15512, a novel topical treatment, has shown promise as a groundbreaking therapy for dry eye disease (DED), a condition that plagues an estimated 38 million individuals in the United States. In pivotal Phase 3 trials, COMET-2 and COMET-3, this TRPM8 agonist, developed by Alcon, a leader in eye care, demonstrated significant efficacy and safety with the primary endpoint being met at a highly statistically significant level (p <0.0001).

These trials, involving over 930 participants, revealed that AR-15512 effectively increased tear production, as evidenced by a 10-mm rise in unanesthetized Schirmer’s score, a standard measure for assessing tear production, by Day 14. This outcome aligns with the drug's proposed mechanism of action and highlights its potential to offer a new and effective management strategy for DED, a chronic ailment that is often inadequately addressed with current prescription treatments.

David Endicott, Alcon's CEO, expressed enthusiasm for AR-15512, stating that it could overcome the limitations of existing treatments and provide a rapid and natural tear production solution for DED patients. He emphasized that AR-15512 is the vanguard of Alcon's emerging pharmaceutical offerings, showcasing the company's ongoing commitment to innovation in eye care.

Despite affecting millions, only a fraction of those diagnosed with DED are treated with prescription products, indicating a pressing need for effective chronic treatments. The Phase 3 studies also indicated that AR-15512 not only offers rapid onset but also maintains its efficacy, with benefits observed as early as Day 1 and sustained up to Day 90. The drug was found to be well-tolerated with no serious ocular adverse events reported.

Dr. Edward Holland, a key advisor on the COMET trials and a Senior Scientific Advisor at Alcon, underscored the importance of rapid onset in dry eye medications, noting that AR-15512 has achieved this in both efficacy and safety studies, positioning it as a first-in-class candidate for chronic dry eye treatment.

As an investigational drug, AR-15512 has yet to be submitted to the FDA for approval and is not commercially available. Alcon is looking forward to filing the New Drug Application (NDA) with the FDA by mid-2024. The company's pharmaceutical portfolio already includes a range of eye care products such as Rocklatan®, Rhopressa®, Simbrinza®, Eysuvis®, and Inveltys®.

Dry eye disease is a prevalent ocular surface disorder, not only affecting the elderly but also impacting a broader demographic due to modern factors like increased digital screen usage. Many current prescription options are considered insufficient due to their low efficacy, slow action, and poor tolerability.

Alcon, with a legacy spanning over 75 years, is dedicated to enhancing sight and improving lives through its comprehensive product portfolio. The company's surgical and vision care products benefit over 260 million people annually across more than 140 countries, addressing conditions such as cataracts, glaucoma, retinal diseases, and refractive errors. Alcon's global team of over 25,000 associates is committed to advancing eye care through innovative products and partnerships with eye care professionals.