TRYPTYR (acoltremon ophthalmic solution 0.003%) stimulates tear production via TRPM8 activation and is now available in the U.S.
An intriguing novel mechanism of action is coming to the American dry eye landscape.
On Tuesday, Alcon (Texas, United States) announced the U.S. commercial launch of TRYPTYR (acoltremon ophthalmic solution 0.003%). The news release comes just a few months after the drug’s FDA approval in May for the treatment of dry eye disease (DED).
READ MORE: Alcon Secures FDA Approval for TRYPTYR for Dry Eye Disease
The launch expands available treatment options for the estimated 38 million U.S. adults affected by dry eye disease.
“TRYPTYR is highly anticipated in the DED treatment space as the first neuromodulator eye drop to rapidly increase natural tear production,” said Lisa Praeger, vice president and general manager of U.S. Ocular Health Pharmaceuticals at Alcon.
“We’re committed to making this option available to eye care professionals and patients seeking new approaches to DED management.”
How does TRYPTYR work?
TRYPTYR’s new approach has intriguing potential.
As a first-in-class transient receptor potential melastatin 8 (TRPM8) receptor agonist, TRYPTYR stimulates corneal sensory nerves to enhance basal tear production. Alcon claims that this addresses potential underlying tear deficiencies, rather than solely managing symptoms.
The targeted TRPM8 receptors are cold-sensing thermoreceptors on the ocular surface which activate trigeminal nerve signaling to boost natural tear production. This neuromodulatory approach contrasts with existing treatments that aim to reduce ocular inflammation.
READ MORE: Dr. Mahnia Madan’s Four-Step Approach to Managing DED
The evidence behind the approval
FDA approval was supported by two Phase III trials, COMET-2 and COMET-3, which enrolled more than 930 patients with DED.
Participants were randomized 1:1 to receive TRYPTYR or vehicle control, one drop per eye two times daily for 90 days. The primary endpoint, a ≥10 mm increase in unanesthetized Schirmer’s score by Day 14, was achieved by 42.6% of TRYPTYR patients in COMET-2 (vs. 8.2% for vehicle) and 53.2% in COMET-3 (vs. 14.4%), with p < 0.0001 in both studies.
While current therapies often require weeks to achieve clinical benefit, TRYPTYR demonstrated increases in tear production as early as Day 1 in the COMET-2 and COMET-3 clinical trials.
These tear production improvements were sustained through Day 90, with no serious ocular adverse events reported. The most common side effect was mild, transient instillation site pain, affecting approximately 50% of patients.
What’s coming to clinics
TRYPTYR is available in preservative-free, single-dose vials, with a recommended dosing of one drop per eye, two times daily. Alcon is offering initial patient support through a First Fill Free trial and copay assistance via BlinkRx, with home delivery for eligible patients.
Thought leaders in the space have since spoken on what this could mean for clinical practice in approved areas.
“TRYPTYR represents an important milestone in the treatment of dry eye disease,” said Dr. Preeya Gupta (United States). “Alcon is also supporting clinicians with educational resources to help integrate new treatments like TRYPTYR into practice.”
With only 13% of surveyed DED patients reporting adequate symptom control and the market projected to reach $9.85 billion by 2028, this rapid-onset, first-in-class therapy could help fill a major treatment gap.
For now, TRYPTYR offers a refreshing option. One that promises to leave both patients and prescribers with a little more sparkle in their eyes.
READ MORE: Alcon Launches SYSTANE PRO Preservative-Free OTC Drops for Dry Eye in the US
Editor’s Note: For more information, please see Alcon’s official press release here.
This content is intended exclusively for healthcare professionals. It is not intended for the general public. Products or therapies discussed may not be registered or approved in all jurisdictions, including Singapore.