Dry Eye Disease (DED) is a prevalent condition affecting millions worldwide, characterized by insufficient or poor-quality tears leading to ocular discomfort and visual disturbances. On May 28, 2025, the U.S. Food and Drug Administration (FDA) approved Tryptyr™ (acoltremon ophthalmic solution) 0.003%, developed by Alcon, marking a significant advancement in DED management.
Understanding Dry Eye Disease
Dry Eye Disease (DED) arises when the eyes fail to produce adequate tears or when the tears evaporate too quickly. This condition can result from various factors, including aging, hormonal changes, environmental conditions, and prolonged screen time. Symptoms often include dryness, burning sensations, blurred vision, and a feeling of grittiness in the eyes.
Introduction of Tryptyr a milestone
Tryptyr is a first-in-class ophthalmic solution designed to address the underlying causes of DED. Its active ingredient, acoltremin, functions as a TRPM8 receptor agonist, targeting specific receptors in the eye to stimulate natural tear production. It is manufactured by Alcon Laboratories, Inc. Fort Worth, TX 76134, U.S.A
Mechanism of Action of Tryptyr
The TRPM8 receptors are cold-sensitive ion channels located on the corneal sensory nerves. Activation of these receptors by Tryptyr leads to:
- Stimulation of Natural Tear Production: Enhancing the body’s ability to produce tears, thereby alleviating dryness.
- Rapid Onset of Action: Patients have reported noticeable improvements as early as the first day of treatment.
Clinical Efficacy: COMET-2 and COMET-3 Trials
The FDA’s approval of Tryptyr was based on the positive outcomes from two pivotal Phase 3 clinical trials:
- COMET-2:
- 42.6% of patients experienced at least a 10mm increase in tear production by day 14, compared to 8.2% in the placebo group.
- COMET-3:
- 53.2% of patients achieved similar improvements, versus 14.4% in the control group.
These results underscore Tryptyr’s rapid and sustained efficacy in enhancing tear production.
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Dosage and Administration
- Dosage: One drop in each eye, twice daily.
- Packaging: Available in preservative-free, single-use vials, ensuring sterility and convenience.
Safety Profile
Tryptyr has demonstrated a favorable safety profile:
- Common Adverse Effects:
- Mild to moderate instillation site pain was reported in approximately 50% of patients.
- Precautions:
- Patients should avoid touching the vial tip to any surface to prevent contamination.
- Contact lenses should be removed prior to administration and can be reinserted after 15 minutes.
Market Potential and Unmet Needs
DED affects an estimated 38 million individuals in the U.S., yet fewer than 10% receive prescription treatments. The introduction of Tryptyr addresses a significant unmet need, offering a novel mechanism of action and rapid symptom relief.
Alcon’s Strategic Vision
As a leader in eye care, Alcon’s development of Tryptyr aligns with its commitment to innovative solutions. Following its spin-off from Novartis in 2019, Alcon has focused on expanding its portfolio to address various ocular conditions.
FAQ
What is Tryptyr and how does it treat Dry Eye Disease (DED)?
Tryptyr is an FDA-approved ophthalmic solution containing 0.003% Acoltremon. It treats Dry Eye Disease by stimulating TRPM8 receptors in the corneal nerves, which boosts natural tear production. Unlike conventional eye drops, it addresses tear deficiency at the neural level, making it a first-in-class treatment.
How soon can I expect relief after using Tryptyr eye drops?
In clinical trials, patients reported significant improvement in natural tear production as early as Day 11, with statistically significant results observed even on Day 1 in some cases. This rapid onset sets Tryptyr apart from many other DED treatments, which typically take longer to show effects.
Is Tryptyr safe for use with contact lenses?
No, Tryptyr should not be used while wearing contact lenses. If you wear lenses, remove them before applying the drops. You can reinsert your contact lenses 15 minutes after using Tryptyr to avoid contamination and ensure effectiveness.
What side effects are associated with Tryptyr?
The most common side effect observed in clinical trials was installation site pain, reported in about 50% of patients. Patients are also advised to avoid touching the dropper tip to any surface, including the eye, to prevent infection or contamination.
When will Tryptyr be available in the market?
Tryptyr is expected to launch in the United States during Q3 2025. Alcon, the manufacturer, also plans to expand availability to global markets in the future, making this innovative dry eye treatment accessible to a broader patient population.
Conclusion
Tryptyr represents a significant advancement in the treatment of Dry Eye Disease, offering rapid relief through a novel mechanism of action. Its approval by the FDA provides healthcare professionals and patients with a new, effective option to manage this widespread condition.
References
- Alcon Announces FDA Approval of TRYPTYR (acoltremon ophthalmic solution) 0.003% for the Treatment of the Signs and Symptoms of Dry Eye Disease. [https://investor.alcon.com/news-and-events/press-releases/news-details/2025/Alcon-Announces-FDA-Approval-of-TRYPTYR-acoltremon-ophthalmic-solution-0-003-for-the-Treatment-of-the-Signs-and-Symptoms-of-Dry-Eye-Disease/default.aspx]
- US FDA approves Alcon’s new dry-eye drug.[https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-alcons-new-dry-eye-drug-2025-05-28/]
- Tryptyr: Uses, Dosage, Side Effects & Warnings. [https://www.ophthalmologytimes.com/view/advancements-in-ophthalmology-a-comprehensive-look-at-the-fda-s-2023-approvals]
- FDA Approves Acoltremon Ophthalmic Solution 0.003% for Signs and Symptoms of Dry Eye Disease.[https://www.drugtopics.com/]
- Alcon Receives FDA Approval for Tryptyr to Treat Dry Eye Disease.[https://www.visionmonday.com/eyecare/article/alcon-receives-fda-approval-for-tryptyr-to-treat-dry-eye-disease]
- FDA Approves Tryptyr Eye Drops for Dry Eye Disease.
