FDA Approves Alcon’s Tryptyr for Dry Eye Disease

Today, the FDA approved Tryptyr (acoltremon ophthalmic solution 0.003%), a new eye drop developed by Alcon, for the treatment of both signs and symptoms of Dry Eye Disease (DED).

Formerly known as AR-15512, Tryptyr is the first FDA-approved treatment in a new class of eye drops that target TRPM8 receptors, stimulating corneal sensory nerves to boost the body’s natural tear production, according to a news release by Alcon.

The product will be packaged in easy-to-use, single-dose vials, with the recommended dosage being one drop per eye, twice daily.

Alcon, a global eye care company known for products such as Systane and GenTeal Tears, plans to launch Tryptyr in the U.S. market in the third quarter of 2025. International rollouts are expected to follow.

The drug’s approval was supported by data from Alcon’s two pivotal phase 3 clinical trials, where more than 930 patients with a history of dry eye were randomized to receive either Tryptyr or a vehicle (placebo) treatment.

According to media reports, company executives have projected peak sales between $250 million and $400 million, depending on how the final FDA labeling supports its use.

Alcon was contacted to confirm Tryptyr's market price, and according to a spokesperson with the company, "Interested customers should contact their Alcon sales rep for pricing information."

The drug’s approval was supported by data from Alcon’s two pivotal phase 3 clinical trials that showed significantly robust results.

In the COMET-2 and COMET-3 studies, more than 930 patients with a history of dry eye were randomized to receive either Tryptyr or a vehicle (placebo) treatment.

The findings revealed that Tryptyr significantly outperformed the control in stimulating natural tear production.

At Day 14, 42.6% of Tryptyr users in COMET-2 and 53.2% in COMET-3 achieved at least a 10mm increase in tear volume, compared to only 8.2% and 14.4% of the control group.

It’s important to note that improvements were seen as early as day 1 and were sustained through day 90.

Experts say these findings could be a turning point in managing a condition that affects millions but is often poorly controlled with current treatments.

“Many of my patients continue to face frustrating challenges with dry eye management, and there is a clear need for additional treatment options,” said Marjan Farid, M.D., professor of ophthalmology at the University of California, Irvine, in the release. “Tryptyr is the first eye drop that stimulates corneal nerves to directly address tear deficiency, a known cause of dry eye disease.”

These clinical benefits are especially significant considering the large population affected by DED and the limitations of existing therapies.

DED is one of the most widespread ocular surface disorders globally, affecting about 38 million adults in the U.S. and over 700 million worldwide.

The condition stems from reduced tear production or faster-than-normal tear evaporation, leading to symptoms such as dryness, stinging, blurred vision, sensitivity to light, and a gritty or foreign body sensation in the eyes.

In some cases, patients even experience excessive reflex tearing caused by irritation of the eye surface.

Although DED is common across age groups, it affects an excessive amount older adults—especially women after menopause.

According to University Hospitals, studies suggest that nearly 75% of people over the age of 65 experience dry eye symptoms.

While prescription treatments are available, many patients and eye care professionals express dissatisfaction due to the slow onset of relief, limited effectiveness or side effects, the release said.

According to a past survey, only 13% of patients felt their dry eye was well managed.

Given the scale of the market and the gaps in current treatment options, Alcon has the potential to capitalize on this approval.

In 2023, the global dry eye products market was valued over $7 billion, having grown at a compound annual growth rate (CAGR) of 3.65% since 2018.

The market is expected to grow from over $7 billion in 2023 to $9.85 billion in 2028 at a rate of 6.31%.

With nearly $10 billion in annual revenue and $2.5 billion in sales in the fourth quarter of 2024 alone—a 6% increase over the previous year—Alcon has the infrastructure and financial backing to support this launch.

Shares of Alcon Inc. are currently trading at around $85.