FDA nod for acoltremon: What its approval means for clinicians and patients

With the approval of acoltremon, eye care providers can offer patients a novel approach to dry eye relief. (Image credit: AdobeStock/zinkevych)

Alcon’s announcement of the FDA approval for its acoltremon ophthalmic solution 0.003% (Tryptyr; formerly AR-15512) for the treatment of signs and symptoms of dry eye disease (DED)^1,2 brings to market a first-in-class TRPM8 receptor agonist (neuromodulator) that stimulates corneal sensory nerves to rapidly increase natural tear production. This approval is supported by two phase 3 clinical trials (COMET-2 and COMET-3) evaluating more than 930 patients (randomly assigned 1:1 to acoltremon or vehicle) with a history of DED.^1,2 

The Eye Care Network reached out to members of the eye care community who specialize in treating DED for their perspectives on this new therapeutic option.

“Those of us who care for patients with dry eye and ocular surface disease know how much these conditions can impact quality of life and are glad to see new therapies being developed to help patients who haven’t responded adequately to currently available therapies,” said Peter J. McDonnell, MD, director of the Wilmer Eye Institute at Johns Hopkins University School of Medicine; the William Holland Wilmer Professor of Ophthalmology at Johns Hopkins School of Medicine; and co–chief medical editor of Ophthalmology Times®.

David Wirta, MD, in private practice in Newport Beach, California, noted that while DED is one of the most common ocular disorders, affecting an estimated 38 million people in the US, only about 18 million are diagnosed, and less than 10% of those are treated with a prescription product.³

Impact on landscape for DED treatment

When asked about the impact this latest FDA approval in the dry eye space might have on the treatment landscape for DED, John D. Sheppard, MD, of Virginia Eye Consultants in Norfolk, Virginia, noted the news brings with it “a new mechanism specifically tailored to the normal neurogenic impetus to tear production.”

He added: “A unique mechanism will likely create a specific sector of patient success related to responsive individuals, perhaps neurotrophic, post LASIK, and patients with pain as well as routine age-related DED.”

Cory Lappin, OD, MS, FAAO, of Phoenix Eye Care in Phoenix, Arizona, noted that the approval of acoltremon adds another dimension to the dry eye armamentarium.

“We have some great treatments that stabilize the tear film, reduce inflammation, and target the neural pathway,” Lappin said, “but acoltremon is the first topical drop that increases tear production using the basal tear pathway through direct stimulation of the corneal nerves via the TRPM8 receptor, which adds a novel mechanism to the fold.”

The efficacy and safety records of acoltremon appear to be within the standards set for useful additions to the prescription palette for the highly heterogenous dry eye population, according to Sheppard. “Tolerability should be acceptable, and the cool sensation created will allow patients to best understand when this drop has actually landed properly on their eye,” he said.

Lappin added that “many of our current treatment options for dry eye work by targeting inflammation, but at this point the patient is already in the ‘vicious cycle’ of dry eye involving tear film instability, inflammation, and ocular surface damage.” Acoltremon addresses dry eye closer to its root cause by working upstream in the disease process by increasing tear production through the basal pathway, which can potentially prevent patients from even entering this vicious cycle, he noted.

Addressing existing gaps in therapy

Direct topical targeting of afferent tear production could prove beneficial for many symptomatic and neurogenically driven patients, treatment-naive patients, and those who have issues with currently available approved medications, according to Sheppard.

Lappin noted that one of the most challenging aspects of dry eye treatment is that many therapeutic options can take several weeks before demonstrating a noticeable effect. Because of its underlying mechanism, acoltremon works rapidly and provides the quick onset of action desired by patients, he said.

“The ability to use a topical drop to directly and rapidly stimulate tear production in the same manner that our own natural basal tears are produced shifts this paradigm by providing [eye care clinicians with] a fast and effective way to address DED,” Lappin said.

“We will all be excited to try a truly unique preparation,” said Sheppard.

Acoltremon is the first neuromodulatory treatment in the form of a topical drop to target the basal tear production pathway directly through the corneal nerves via the TRPM8 receptor, Lappin noted.

“The idea of leveraging this natural pathway to produce the body’s own tears will likely resonate with both doctors and patients, which I think will lead to a high amount of receptivity and clinical implementation,” he said.

Acoltremon will be available in single-dose vials: 1 drop per eye, 2 times a day. Alcon said in a prepared statement that it expects to launch acoltremon in the US in the third quarter of 2025 and anticipates bringing the product to other markets in the future.¹

References

1. Alcon announces FDA approval of Tryptyr (acoltremon ophthalmic solution) 0.003% for the treatment of the signs and symptoms of dry eye disease. News release. Alcon. May 28, 2025. Accessed May 29, 2025. https://www.alcon.com/media-release/alcon-announces-fda-approval-tryptyr-acoltremon-ophthalmic-solution-0003-treatment/

2. Maharjan EK, Harp MD. FDA approves Alcon’s Tryptyr (AR-15512) for signs and symptoms of dry eye disease. Ophthalmology Times. May 29, 2025. Accessed June 6, 2025. https://www.ophthalmologytimes.com/view/fda-approves-alcon-s-tryptyr-ar-15512-for-signs-and-symptoms-of-dry-eye-disease

3. Karpecki PM, Nichols KK, Sheppard JD. Addressing excessive evaporation: an unmet need in dry eye disease. Am J Manag Care. 2023;29(suppl 13):S239-S247. doi:10.37765/ajmc.2023.89448