Tryptyr (Acoltremon) Wins FDA Nod, Offering a New Mechanism for Treating Dry Eye Disease

Alcon’s newly approved eye drop, Tryptyr (acoltremon ophthalmic solution) 0.003%, is set to expand treatment options for dry eye disease in the US.

The FDA has approved Tryptyr as the first TRPM8 receptor agonist for treating both the signs and symptoms of dry eye disease, a condition that affects an estimated 38 million Americans.

Dry eye disease occurs when the eyes produce too few tears or when tears evaporate too quickly. This leads to symptoms like burning, blurry vision and a gritty feeling. Aging, autoimmune diseases and digital screen use are common risk factors.

Many treatment options rely on lubricating drops, anti-inflammatory medications and tear-conserving procedures, but these solutions often leave gaps in long-term relief.

A commentary in Ophthalmology and Therapy described how symptoms can hinder work productivity, travel and daily comfort. Dry eye disease patients tend to cycle through multiple therapies and deal with financial barriers and insurance hurdles.

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

Tryptyr’s active ingredient, acoltremon, targets TRPM8 receptors on corneal sensory nerves, stimulating natural tear production and thereby the eye’s natural hydration mechanism. While the precise mechanism in humans isn’t fully understood, animal studies have supported the role of this pathway in enhancing basal tear secretion.

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The FDA approval was based on two pivotal Phase III trials, COMET-2 and COMET-3, which involved over 930 participants with a history of dry eye disease. By Day 14, up to four times more patients using acoltremon experienced at least a 10-mm increase in natural tear production compared to placebo — 42.6% versus 8.2% in COMET-2 and 53.2% versus 14.4% in COMET-3.

Some patients saw measurable improvements as early as the first day of treatment, with consistent effects observed through three months.

Despite the positive outcomes, however, the most common side effect reported in clinical trials was instillation site pain (discomfort upon application), occurring in about 50% of patients.

DelveInsight’s 2025 dry eye disease market report estimates the market at $3.7 billion across the US and other major markets, with over 54 million diagnosed patients — yet fewer than 10% currently receive prescription treatments.

A few investigational therapies are moving ahead this year, including Palatin’s PL9643, which has shown complete symptom resolution in Phase III clinical trials by targeting the melanocortin receptor system; Aldeyra’s reproxalap, demonstrating significant reductions in ocular discomfort in a Phase III trial; and broader inflammation-modulating treatments like immunoglobulin eye drops from Selagine, currently in Phase II, and Iolyx’s ILYX-002, a topical immunomodulator in Phase II development targeting autoimmune-driven dry eye disease.

Alcon plans to launch Tryptyr in the US in the third quarter of 2025 and anticipates expanding its availability in international markets.

In April 2025, Alcon also launched its UNITY Vitreoretinal Cataract System (VCS) and UNITY Cataract System (CS), advanced surgical platforms designed to improve efficiency and patient outcomes in eye surgery.

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