FDA Approves Tryptyr (acoltremon) Ophthalmic Solution for the Treatment of Dry Eye Disease

Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly,  announced the U.S. Food and Drug Administration (FDA)  approval of  Tryptyr® (acoltremon ophthalmic solution) 0.003%, formerly known as AR-15512, for the treatment of signs and symptoms of Dry Eye Disease (DED).  Tryptyr is a first-in-class TRPM8 receptor agonist (neuromodulator) that stimulates corneal sensory nerves to rapidly increase natural tear production. 

                                                                           Acoltremon 

DED is a complex, multifactorial condition driven by a deficiency in natural tears, whether due to decreased tear production or increased tear evaporation.5-7 Many commonly used DED treatment options have limitations, including slow onset, patient dissatisfaction and poor adherence.8-14 Among surveyed dry eye patients, only 13% felt their dry eye was well managed.14*

“Today marks a tremendous milestone for Alcon as Tryptyr becomes our first prescription pharmaceutical treatment to be approved by the FDA since becoming an independent, publicly traded eye care company,” said David Endicott, CEO of Alcon. “We look forward to making this new treatment available to millions of patients affected by Dry Eye Disease. We believe Tryptyr is an exciting new treatment option for a significant number of dry eye patients given its rapid efficacy.”

This approval is supported by two Phase 3 clinical trials evaluating more than 930 patients (randomized 1:1 to Tryptyr or vehicle) with a history of DED.1-2 In COMET-2 and COMET-3, up to four times more Tryptyr patients experienced at least a 10mm increase in natural tear production at Day 14, compared to vehicle, 42.6% versus 8.2% of patients in COMET-2 and 53.2% versus 14.4% in COMET-3 (both p<0.0001).1-2 Consistent results were observed at all timepoints through Day 90. Tryptyr demonstrated statistically significant natural tear production as early as Day 1.1-2

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

Studies in animals suggest that acoltremon, the active substance in Tryptyr, is an agonist of transient receptor potential melastatin 8 (TRPM8) thermoreceptors. TRPM8 thermoreceptor stimulation has been shown to activate trigeminal nerve signaling leading to increased basal tear production. The exact mechanism of action for Tryptyr in DED is unknown.

Tryptyr is available in easy-to-use, single dose vials: one drop per eye, two times a day.3 Alcon expects to launch Tryptyr in the U.S. in the third quarter of 2025 and anticipates bringing Tryptyr to other markets in the future.

INDICATIONS AND USAGE

Tryptyr (acoltremon ophthalmic solution) 0.003% is indicated for the treatment of the signs and symptoms of dry eye disease (DED).

https://en.wikipedia.org/wiki/Acoltremon#:~:text=Society%20and%20culture-,Legal%20status,under%20the%20brand%20name%20Tryptyr.

FDA Approves Tryptyr (acoltremon) Ophthalmic Solution for the Treatment of Dry Eye Disease

FDA Approves Tryptyr (acoltremon) Ophthalmic Solution for the Treatment of Dry Eye Disease

Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly,  announced the U.S. Food and Drug Administration (FDA) approval of  Tryptyr® (acoltremon ophthalmic solution) 0.003%, formerly known as AR-15512, for the treatment of signs and symptoms of Dry Eye Disease (DED).3 Tryptyr is a first-in-class TRPM8 receptor agonist (neuromodulator) that stimulates corneal sensory nerves to rapidly increase natural tear production.3

DED is a complex, multifactorial condition driven by a deficiency in natural tears, whether due to decreased tear production or increased tear evaporation.5-7 Many commonly used DED treatment options have limitations, including slow onset, patient dissatisfaction and poor adherence.8-14 Among surveyed dry eye patients, only 13% felt their dry eye was well managed.14*

“Today marks a tremendous milestone for Alcon as Tryptyr becomes our first prescription pharmaceutical treatment to be approved by the FDA since becoming an independent, publicly traded eye care company,” said David Endicott, CEO of Alcon. “We look forward to making this new treatment available to millions of patients affected by Dry Eye Disease. We believe Tryptyr is an exciting new treatment option for a significant number of dry eye patients given its rapid efficacy.”

This approval is supported by two Phase 3 clinical trials evaluating more than 930 patients (randomized 1:1 to Tryptyr or vehicle) with a history of DED.1-2 In COMET-2 and COMET-3, up to four times more Tryptyr patients experienced at least a 10mm increase in natural tear production at Day 14, compared to vehicle, 42.6% versus 8.2% of patients in COMET-2 and 53.2% versus 14.4% in COMET-3 (both p<0.0001).1-2 Consistent results were observed at all timepoints through Day 90. Tryptyr demonstrated statistically significant natural tear production as early as Day 1.1-2

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

Studies in animals suggest that acoltremon, the active substance in Tryptyr, is an agonist of transient receptor potential melastatin 8 (TRPM8) thermoreceptors. TRPM8 thermoreceptor stimulation has been shown to activate trigeminal nerve signaling leading to increased basal tear production. The exact mechanism of action for Tryptyr in DED is unknown.

Tryptyr is available in easy-to-use, single dose vials: one drop per eye, two times a day.3 Alcon expects to launch Tryptyr in the U.S. in the third quarter of 2025 and anticipates bringing Tryptyr to other markets in the future.

Ref: https://en.wikipedia.org/wiki/Acoltremon

FDA Approves Miebo (perfluorohexyloctane) Ophthalmic Solution for the Treatment of the Signs and Symptoms of Dry Eye Disease

Bausch + Lomb Corporation, announced that the U.S. Food and Drug Administration (FDA) has approved Miebo™ (perfluorohexyloctane ophthalmic solution; formerly known as NOV03), for the treatment of the signs and symptoms of dry eye disease (DED). Miebo is the first and only FDA-approved treatment for DED that directly targets tear evaporation.

“Today’s FDA approval of Miebo further advances DED treatment by addressing a significant unmet need for millions of people suffering with this disease,” said Brent Saunders, chairman and CEO, Bausch + Lomb. “We are proud to bring to market the first and only prescription eye drop approved in the United States for the treatment of DED that directly targets evaporation. We expect to make Miebo commercially available in the second half of this year.”

DED affects millions of Americans and is one of the most common ocular surface disorders.1 A leading cause of DED is excessive tear evaporation, which due to an altered tear lipid layer, is often associated with the clinical signs of Meibomian gland dysfunction (MGD). An unstable tear film triggers increased ocular surface desiccation, inflammation and damage to the ocular surface.2,3 Miebo is designed to reduce tear evaporation at the ocular surface.4,5

In GOBI and MOJAVE, two phase 3 pivotal clinical trials which enrolled more than 1,200 patients (randomized 1:1 to Miebo or hypotonic saline) with a history of DED and clinical signs of MGD, Miebo consistently met its primary clinical sign and patient-reported symptom endpoint.

"In the two pivotal clinical trials, Miebo addressed the persistent and chronic nature of DED by providing sustained improvement in both the signs and symptoms of DED,” said Preeya Gupta, M.D., cornea and cataract surgeon, Triangle Eye Consultants, Raleigh, North Carolina. “Because Miebo inhibits evaporation, it may be an appropriate treatment option for patients whose tear evaporation exceeds tear supply.”

“Tear evaporation, which is a leading driver of DED, presents a significant treatment challenge. With the approval of Miebo, eye care professionals can now take a new approach to DED therapy with a first-in-class water- and preservative-free prescription treatment option that specifically addresses tear evaporation,” said Paul Karpecki, O.D., director, Cornea and External Disease, Kentucky Eye Institute, and associate professor, University of Pikeville, Kentucky College of Optometry.

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