FDA Approves Alcon's TRYPTYR for Dry Eye Disease Symptoms

Alcon, a leading global company in eye care, announced that the U.S. Food and Drug Administration (FDA) has approved TRYPTYR®, an ophthalmic solution known for treating Dry Eye Disease (DED). This marks a significant achievement for Alcon, as TRYPTYR is their first prescription pharmaceutical approved by the FDA since Alcon became an independent company.

TRYPTYR represents a breakthrough in DED treatment as it is the first TRPM8 receptor agonist that directly stimulates corneal sensory nerves. This stimulation results in a rapid increase in tear production, addressing a deficiency of natural tears, which is a primary factor in DED. Dry Eye Disease affects millions globally, with symptoms often resulting from either reduced tear production or increased tear evaporation. Traditional treatments for DED have limitations, such as slow onset and poor patient adherence, which have led to dissatisfaction among patients. A survey revealed that only 13% of DED patients felt their condition was adequately managed.

The approval of TRYPTYR is based on two extensive Phase 3 clinical trials, known as COMET-2 and COMET-3. These trials involved over 930 participants and demonstrated TRYPTYR's effectiveness. In comparison to the control vehicle, patients using TRYPTYR showed a significant increase in natural tear production. Notably, up to four times more patients experienced a 10mm increase in tear production by Day 14 compared to those in the control group. Consistent results were seen over the course of 90 days, with significant improvement noted as early as Day 1.

Dr. Marjan Farid, a professor of ophthalmology, emphasized the need for more effective DED treatments and praised TRYPTYR for directly addressing tear deficiency through corneal nerve stimulation. TRYPTYR's active ingredient, acoltremon, acts as an agonist to TRPM8 thermoreceptors, which are thought to activate trigeminal nerve signaling, leading to increased tear production. Though the precise mechanism remains unknown, animal studies suggest promising outcomes.

TRYPTYR is designed for easy use, provided in single-dose vials to be used twice daily. Alcon plans to launch TRYPTYR in the U.S. by the third quarter of 2025 and aims to expand availability to other markets.

The newly approved solution is intended to treat the signs and symptoms of DED effectively. However, safety precautions must be considered. Patients are advised not to touch the vial tip to the eye or other surfaces to avoid contamination. Moreover, TRYPTYR should not be used while wearing contact lenses, which should be removed prior to application and reinserted 15 minutes later.

In clinical trials, the most common side effect reported was pain at the site of instillation in 50% of participants. Dry Eye Disease is one of the most prevalent ocular disorders, affecting millions in the U.S. and hundreds of millions more worldwide. While it was once believed to primarily affect older populations, factors like increased digital screen usage have contributed to its rising incidence across different ages and genders.

Alcon has over 75 years of experience in enhancing eye health and offers a diverse range of products that benefit over 260 million individuals in more than 140 countries. Their innovations and partnerships with eye care professionals continue to improve the quality of life for those with various eye conditions.