Mode
Text Size
Log in / Sign up

Acoltremon 0.003% twice daily increased tear production in adults with Dry Eye DiseaseNew dry eye treatment boosts tear production in adults over 30

AI-generated summary of the cited source, checked by automated accuracy review. How we work

Key Takeaway
Consider acoltremon 0.003% for tear production increase in Dry Eye Disease, noting mild instillation-site burning.

Two randomized, multicenter, double-masked, vehicle-controlled phase 3 studies (COMET-2, N = 465; COMET-3, N = 466) enrolled adults aged 30 years or older with Dry Eye Disease. Participants had a total corneal fluorescein staining score of 2 or more and 15 or less, anesthetized Schirmer test score of 2 or more and less than 10 mm/5 min, and ocular discomfort and SANDE scores of 50 or more.

The intervention was acoltremon 0.003% twice daily; the comparator was vehicle twice daily. The primary outcome was the proportion achieving a 10-mm or greater increase in unanesthetized Schirmer test score on day 14. In COMET-2, 42.6% of acoltremon patients versus 8.2% of vehicle patients achieved this (P < 0.0001). In COMET-3, the rates were 53.2% versus 14.4% (P < 0.0001).

Secondary outcomes favored acoltremon. Global SANDE score reduction by day 28 was statistically significant in COMET-2. Tear production increased as early as day 1 through day 90 (P < 0.0001). Greater reductions in total corneal fluorescein staining were observed on days 28 and 90, and in total conjunctival staining at all time points.

Safety was acceptable. Mild instillation-site burning or stinging was the only ocular adverse event reported with an incidence greater than 2.5%. Serious adverse events and discontinuations were not reported. Key limitations include the 90-day follow-up and the specific population criteria. Practice relevance was not reported.

Dry eye disease leaves many adults staring at a screen or reading a book while their eyes burn. For people aged 30 and older with a confirmed diagnosis, a new treatment called acoltremon offered real relief. In two large studies involving nearly 930 patients, this medication helped eyes produce more tears and feel less pain.

The treatment was used twice daily for up to 90 days. By day 14, more than 42 percent of patients using acoltremon saw their tear production jump by 10 millimeters or more. This was a big improvement compared to those using a vehicle, which had no active medicine. By day 28, patients reported less overall eye discomfort. These benefits continued through day 90.

The medication also reduced staining on the eye surface, a sign of irritation. The only side effect reported was mild burning or stinging where the drops were placed. This happened in a small number of people and was the only issue that occurred more than 2.5 percent of the time. No serious problems were found during the trials.

While these results are promising, remember that this data comes from specific clinical trials. The study did not report how long these effects last after stopping the drops. Always talk to a doctor before starting any new eye medication.

What this means for you:
A new dry eye treatment boosted tear production and reduced discomfort in adults over 30.

Study Details

Study typeRct
Sample sizen = 465
EvidenceLevel 2
Follow-up360.0 mo
PublishedMay 2026
View Original Abstract ↓
PURPOSE: To evaluate the safety and efficacy of the transient receptor potential melastatin 8 agonist acoltremon on signs and symptoms of dry eye disease (DED). DESIGN: Two identical randomized, multicenter, double-masked, vehicle-controlled phase 3 studies. PARTICIPANTS: Adults aged 30 years or older with a DED diagnosis, at least 1 eye with both total corneal fluorescein staining (tCFS) score of 2 or more and 15 or less (no region scoring less than 3) and anesthetized Schirmer test score of 2 or more and less than 10 mm/5 min, and both ocular discomfort (visual analog scale) and Symptom Assessment iN Dry Eye (SANDE) scores of 50 or more. METHODS: Patients (COMET-2, N = 465; COMET-3, N = 466) were randomized 1:1 to acoltremon 0.003% (ACO) or vehicle twice daily for 90 days (ClinicalTrials.gov identifiers: COMET-2, NCT05285644; COMET-3, NCT05360966). MAIN OUTCOME MEASURES: The primary end point was the proportion of patients achieving a 10-mm or greater increase in unanesthetized Schirmer test (UST) score on day 14. The key secondary end point was change from baseline (CFB) in global SANDE score on day 28. Additional secondary end points included CFB in UST on days 1 and 90. Exploratory end points included CFB in tCFS and total conjunctival staining. RESULTS: The primary end point was met in both studies, with more patients receiving ACO achieving a 10-mm or greater increase in UST on day 14 (ACO vs. vehicle: COMET-2, 42.6% vs. 8.2%; COMET-3, 53.2% vs. 14.4%; P < 0.0001 for both). Reduction in global SANDE score by day 28 (key secondary end point) favored ACO in both studies, and was statistically significant in COMET-2. Increased tear production favored ACO versus vehicle as early as day 1 through day 90 in both studies (P < 0.0001). Greater reductions with ACO were observed in tCFS on days 28 and 90 and in total conjunctival staining at all time points. Mild instillation-site burning/stinging was the only ocular adverse event reported with an incidence of more than 2.5%. CONCLUSIONS: In COMET-2 and COMET-3, ACO compared with vehicle led to consistent, clinically meaningful tear production and reductions in DED signs and symptoms. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
Free Newsletter

Clinical research that matters. Delivered to your inbox.

Join thousands of clinicians and researchers. No spam, unsubscribe anytime.