New phase 3b data on Alcon’s TRYPTYR (acoltremon ophthalmic solution) 0.003% for the treatment of the signs and symptoms of dry eye disease (DED) is offering further insights into the stimulated tear response among patients.
The findings were presented during the 2025 American Academy of Optometry annual meeting in Boston, Massachusetts, this week.
Hold up—didn’t the FDA already approve TRYPTYR?
Indeed, it did (in May 2025). This was a notable milestone for Alcon, as the DED eye drop became its first prescription-based pharmaceutical.
Gotcha. So what should we know about it?
TRYPTYR is a topical transient receptor potential melastatin 8 agonist (TRPM8) formulated for topical ocular instillation.
In regard to TRPM8: This cold-sensing, cornea-located receptor leads to increased basal tear production due to its activation of trigeminal nerve signaling.
- Learn more about its mechanism of action.
And keep in mind: TRPM8 is referred to as the “master regulator of tear production,” according to Michelle Senchyna, PhD, global clinical lead of Alcon’s acoltremon program, during an Alcon media briefing on Oct. 9.
And what dosage is recommended?
Packaged in single-dose vials, one drop should be instilled in each eye twice daily (BID; approximately 12 hours apart).
- See its full prescribing information.
Now to the clinical data—starting with its original phase 3 findings.
Two multicenter trials found TRYPTYR to result in a demonstration of rapid onset and sustained tear production as early as Day 14 through Day 90.
Check out those details—as well as additional findings from one other phase 3 trial.
- And, importantly, these studies utilized unanesthetized Schirmer’s testing (measured by patients with a ≥ 10 mm increase in unanesthetized Schirmer score) as the primary outcome measures—a stark difference from this phase 3b study.
Talk about the new reporting.
Prior to TRYPTYR’s FDA approval, investigators initiated an open-label, single-dose, single-arm study (NCT06544707) on the eye drop.
The study’s purpose: To determine the concentration of total lipids in TRYPTYR-stimulated tears via a noninvasive method based on optical coherence tomography (OCT) imaging of the central tear meniscus height (TMH).
Why focus on TMH?
A key reference parameter in DED diagnosis, TMH is typically used to estimate tear volume.
The healthy normal range range is between 0.2 and 0.4 mm—anything < 0.25 mm is indicative of DED.
- And as Senchyna noted, TMH is considered a “clinically-friendly measure.”
How was the study setup?
A total of 41 DED patients received a dosing of TRYPTYR in both eyes, with the following measurements obtained at baseline and 3 minutes after administration:
- In the left eye: OCT imaging of TMH
- In the right eye: Tears collected for lipid analysis
For the tear collection: Investigators partnered with a laboratory at the University of Florida to assist in digitally quantifying lipid concentration.
Now to the findings.
Take note: The data readout—titled Acoltremon 0.003% leads to a statistically significant increase in tear volume and tear total lipid concentration: phase 3b study results—was presented during AAO on Oct. 9 by Nathan Lighthizer, OD.
And as for the data itself: From baseline to 3 minutes after TRYPTYR administration, patients’ mean TMH skyrocketed 147%.
- The numbers: 343 μm at baseline vs 847 μm (p = 0.001) post-administration
And for tear lipid concentration?
Patients’ geometric mean total lipid concentration increased 72% from baseline to 3 minutes-post administration.
- Those numbers: 128 ng/μL vs 221 ng/μL, respectively (p = 0.0143)
Also keep in mind: Individual components of lipids were not measured or broken down into individual classes—just the total lipid concentration was taken into account.
So, based on the findings … what was concluded?
From the perspective of one dry eye expert—Cory Lapin, OD, FAAO, founder of the soon-to-be-open The Dry Eye Center of Ohio in Montgomery, Ohio—these results are “clinically meaningful.”
“It confirms what we were looking for,” he said, speaking on the study’s success in using an alternative form of measurement from Schirmer’s test (as was used in prior phase 3 studies on the eye drop).
- “It’s a bi-directional validation that you’re seeing this consistently, regardless of how it’s measured (or the disease cause,” Dr. Lappin added.
“There's really not going to be any (dry eye) patient, regardless of where they're at (in the disease), who wouldn't benefit from an increase in natural tear production.”
Last question: Has TRYPTYR launched in the U.S. yet?
Oh yes—a few months ago, in fact.
Learn about how to get started prescribing the drop by clicking here.
The American Academy of Optometry (AAO) annual meeting is taking place Oct. 8-11, 2025, in Boston, Massachusetts.