The FDA has recently approved a groundbreaking new treatment for dry eye disease (DED), a condition affecting millions of people in the United States. This new drug, named acoltremon and marketed under the brand name Tryptyr, has shown promising results in stimulating natural tear production rapidly, sometimes as early as the first day of use.
Dry eye disease is characterized by insufficient tear production or rapid tear evaporation, leading to symptoms such as burning, itching, sensitivity to light, blurry vision, and a gritty or sandy sensation in the eyes. While once believed to mainly impact older adults, dry eye disease now affects individuals across all age groups, partly due to increased screen time in today’s digital world. Current treatments often provide only slow relief or fail to tackle the underlying causes, making the need for more effective therapies clear.
Tryptyr stands out as the first treatment designed to directly stimulate tear production by targeting the nerves in the eye. This innovative approach has the potential to benefit approximately 38 million people in the U.S. living with DED, a condition where less than 10% currently use prescription treatments.
The approval by the FDA was based on two significant late-stage clinical trials involving roughly 930 participants diagnosed with dry eye disease. In these studies, participants were randomly given either Tryptyr or a placebo, with results showing that Tryptyr significantly improved tear production. By the 14th day of treatment, up to four times more individuals using Tryptyr experienced an increase in tear production compared to those receiving the placebo. Specifically, 42.6% and 53.2% of Tryptyr users showed improvement in the respective trials, compared to just 8.2% and 14.4% in the placebo groups. Moreover, symptom relief was noted as early as day one of treatment and lasted through the 90-day study period.
The mechanism behind Tryptyr’s effectiveness lies in its ability to activate TRPM8 proteins, which stimulate corneal nerves responsible for tear secretion. This direct stimulation encourages the eye to produce more natural tears, addressing the root cause of dry eye rather than merely managing symptoms.
Tryptyr is administered via single-use vials, with the recommended dosage being one drop in each eye twice daily. This convenient regimen may improve adherence among patients who find current treatments difficult to use consistently or slow to deliver results. The manufacturer plans to make Tryptyr available in the United States by the third quarter of 2025.
One of the major advantages of this new treatment is its potential to overcome many challenges faced by patients with dry eye disease. Existing treatments often fail to deliver prompt relief or target the fundamental issues causing tear deficiency. Tryptyr’s novel mode of action stimulating corneal nerves could change how dry eye disease is managed, offering faster and more effective symptom control.
The trials did report some side effects, with the most common being pain or discomfort in the eyes. However, these effects were generally mild and did not outweigh the overall benefits observed in tear production and symptom relief.
As dry eye disease becomes increasingly prevalent due to lifestyle changes and environmental factors, having a treatment like Tryptyr could be a significant step forward. For many patients, this approval represents hope for a more effective, user-friendly option that addresses the core problem of tear deficiency rather than just masking symptoms.
In summary, the FDA’s approval of Tryptyr marks a notable advancement in the treatment of dry eye disease. By directly targeting the nerves that regulate tear production, Tryptyr offers a new mechanism to combat this common and often debilitating condition. With promising clinical trial results showing rapid and sustained improvement in tear production and symptoms, Tryptyr may soon become a valuable option for millions seeking relief from dry eye discomfort. The availability of this treatment later in 2025 could usher in a new era for managing dry eye disease, improving quality of life for many who struggle with this condition daily.
