Alcon Announces Positive Topline Results From Phase 3 COMET Trials of AR-15512, a Novel Topical Drug Candidate for Dry Eye

Rhea-AI Summary

Alcon (ALC) 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 trials, the primary endpoint of the proportion of subjects with at least a 10-mm increase in unanesthetized Schirmer’s score achieved statistical significance at Day 14 [p<0.0001]. Dry eye affects an estimated 38 million people in the U.S. and less than 10% of diagnosed patients are treated with a prescription product. AR-15512 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.

Medical Research Analyst

The release of positive Phase 3 clinical trial results for AR-15512, a treatment for dry eye disease (DED), represents a significant milestone in the field of ophthalmology. The successful achievement of the primary endpoint in both COMET-2 and COMET-3 studies indicates a statistically significant improvement in tear production, as measured by the Schirmer's score. This is particularly noteworthy given the chronic nature of DED and the current under-treatment of the condition, with less than 10% of diagnosed patients receiving prescription products.

From a medical research perspective, the mechanism of action of AR-15512 as a TRPM8 agonist could offer a novel approach to DED management. TRPM8 traditionally has been associated with cold-temperature sensation and its role in tear film stability and ocular surface health is an area of emerging research. The potential market impact of AR-15512 could be substantial, considering the prevalence of DED in the U.S. population.

Financial Analyst

Alcon's announcement of the positive results from AR-15512's Phase 3 trials is likely to have a considerable impact on the company's financial outlook. Given the large potential market with an estimated 38 million Americans affected by DED, the introduction of an effective prescription product could generate significant revenue streams for Alcon. Additionally, being a first-in-class product candidate, AR-15512 could capture a sizeable market share, especially considering the current gap in treatment adoption.

Investors should monitor the progress of AR-15512 towards regulatory approval and market entry, as these stages are crucial for translating clinical success into commercial success. Moreover, the company's expansion into the ophthalmic pharmaceutical portfolio signals a strategic move that could diversify revenue sources and reduce reliance on its traditional medical devices business.

Market Research Analyst

The dry eye disease market is characterized by a high prevalence yet low treatment rate, indicating a significant unmet medical need. AR-15512's promising clinical trial results suggest it could become a key player in this space. Market research would focus on understanding the patient population, the competitive landscape and the potential adoption rates of new treatments like AR-15512.

It's important to consider the patient journey, from awareness and diagnosis to treatment. The fact that less than 10% of diagnosed DED patients are currently treated with prescription products suggests a large opportunity for market growth, provided that barriers to treatment are addressed, such as awareness and accessibility. Additionally, the impact of AR-15512 on quality of life and productivity for sufferers could influence its adoption and reimbursement policies, further shaping the market dynamics.

• 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)
• Dry eye affects an estimated 38 million people in the U.S. and less than 10% of diagnosed patients are treated with a prescription product¹

GENEVA--(BUSINESS WIRE)-- Regulatory News:

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 U.S., only about 18 million are diagnosed and less than 10% of those diagnosed are treated with a prescription product. This represents the significant need for an effective chronic treatment that can provide rapid natural tear production.¹

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 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.”

AR-15512 is an investigational drug product that has not been submitted to the U.S. Food and Drug Administration (FDA) for approval and is not currently commercially available. Alcon anticipates filing the NDA for AR-15512 with FDA in mid-2024.

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 the United States and an estimated 719 million more adults globally.¹ While once considered a disease of aging populations, modern advancements, such as prolonged digital screen time, have contributed to a significant rise in DED across age and gender.² Many existing prescription options for dry eye disease are generally regarded by many eye care professionals and patients as inadequate due to low treatment efficacy, slow onset of action and/or poor tolerability.³

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.

Cautionary Note Regarding Forward-looking Statements
This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “commitment,” “look forward,” “maintain,” “plan,” “goal,” “seek,” “target,” “assume,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will” and similar references to future periods.

Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties and risks that are difficult to predict. Some of these factors are discussed in our filings with the United States Securities and Exchange Commission, including our Form 20-F. Should one or more of these uncertainties or risks materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated. Therefore, you should not rely on any of these forward-looking statements.

Forward-looking statements in this press release speak only as of the date they are made, and we assume no obligation to update forward-looking statements as a result of new information, future events or otherwise.

References

1. Market Scope 2023 Dry Eye Product Market Review; does not include OTC artificial tears and other Rx anti-inflammatory and tear stimulants.
2. The Relationship Between Dry Eye Disease and Digital Screen Use - PMC (nih.gov)
3. 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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Investor Relations

Daniel Cravens

Allen Trang

+ 41 589 112 110 (Geneva)

+ 1 817 615 2789 (Fort Worth)

investor.relations@alcon.com



Media Relations

Steven Smith

+ 41 589 112 111 (Geneva)

+ 1 682 551 8057 (Fort Worth)

globalmedia.relations@alcon.com

Source: Alcon Inc. Swiss

What are the results of the Phase 3 clinical trials for AR-15512 conducted by Alcon (ALC)?

The results of the Phase 3 clinical trials (COMET-2 and COMET-3) evaluating the efficacy and safety of AR-15512 showed that the primary endpoint of the proportion of subjects with at least a 10-mm increase in unanesthetized Schirmer’s score achieved statistical significance at Day 14 [p<0.0001].

How many people in the U.S. are affected by dry eye disease?

An estimated 38 million people in the U.S. are affected by dry eye disease.

What is the potential of AR-15512 in addressing the limitations of current dry eye prescription options?

AR-15512 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.

Who is the CEO of Alcon (ALC)?

David Endicott is the CEO of Alcon.