Drugs / Acoltremon
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed dry eye syndrome 1 milestone | |||||
| Filed | US (FDA) | — | dry eye syndrome | 2024-10-15 | “AR-15512 is an investigational drug product that has been filed with the U.S. Food and Drug Administration (FDA) for approval; it is not yet approved.” alcon.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | TRYPTYR | — | 2025-05-28 | fda.gov ↗ |
Trials 15
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05497479 | Dec 2021 | dry eye syndrome | Aerie Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03162094 | Apr 2017 → Dec 2018 | dry eye syndrome | Avizorex Pharma, S.L. | Unknown | No outcome recorded |
| Phase 21 trial · 1 missed | ||||||
| Phase 2 | NCT04498182 | Oct 2020 → Jul 2021 | dry eye syndrome | Aerie Pharmaceuticals | Completed | Missed primary |
| Phase 36 trials · 2 met primary | ||||||
| Phase 3 | NCT06660290 | Jan → Feb 2025 | dry eye syndrome | Alcon Research | Completed | No outcome recorded |
| Phase 3 | NCT06544707 | Oct 2024 → Jan 2025 | dry eye syndrome | Alcon Research | Completed | No outcome recorded |
| Phase 3 | NCT06544694 | Oct 2024 → Mar 2025 | dry eye syndrome | Alcon Research | Completed | No outcome recorded |
| Phase 3 | NCT05493111 | Nov 2022 → Feb 2024 | dry eye syndrome | Aerie Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT05360966 | Jul 2022 → Oct 2023 | dry eye syndrome | Aerie Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT05285644 | May 2022 → Jul 2023 | dry eye syndrome | Aerie Pharmaceuticals | Completed | Met primary |
| Phase 46 trials | ||||||
| Phase 4 | NCT07502378 | Mar 2026 → Mar 2027 expected | eye adnexa disorder, neurotrophic keratopathy | University of South Florida | Recruiting | No outcome recorded |
| Phase 4 | NCT07267481 | Dec 2025 → Apr 2026 overdue | dry eye syndrome | Southern College of Optometry | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07281950 | Dec 2025 → Nov 2026 expected | dry eye syndrome | Center for Sight Las Vegas | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07277257 | Dec 2025 → Dec 2026 expected | keratoconjunctivitis | Center For Sight | Recruiting | No outcome recorded |
| Phase 4 | NCT07267299 | Dec 2025 → Apr 2026 overdue | dry eye syndrome | Southern College of Optometry | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07266948 | Nov 2025 → Jan 2026 overdue | dry eye syndrome | Southern College of Optometry | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2025-06-25 | Alcon Research | Results Championing Patient-Focused Innovation: Alcon Highlights Recently Approved TRYPTYR, MARLO Advancements and More at Optometry’s Meeting 2025 alcon.com ↗
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 than patients not using TRYPTYR, 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). |
| 2025-05-28 | Alcon Research | Regulatory Alcon Announces FDA Approval of TRYPTYR (acoltremon ophthalmic solution) 0.003% for the Treatment of the Signs and Symptoms of Dry Eye Disease alcon.com ↗ |
| 2025-02-27 | Alcon Research | Results Alcon Unveils Latest Contact Lens, Dry Eye and Digital Innovations at SECO 2025 alcon.com ↗
New Phase 3 clinical study results presented for AR-15512 (Acoltremon 0.003%), a potential new pharmaceutical treatment option for DED |
| 2024-01-09 | Alcon Research | Results Alcon Announces Positive Topline Results From Phase 3 COMET Trials of AR-15512, a Novel Topical Drug Candidate for Dry Eye alcon.com ↗ |
All press releases naming this drug 7 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | acoltremon | “effectiveness of acoltremon ophthalmic solution 0.003% (ACO [Tryptyr®]), a recently approved treatment for DED signs and symptoms, on visual-tasking ADLs and WP.” PMID 42470519 ↗ Jul 20267“acoltremon ophthalmic solution 0.003% (ACO [Tryptyr®]), a recently approved treatment for DED signs and symptoms” PMID 42470519 ↗ Jul 2026 “TRYPTYR (Acoltremon ophthalmic solution 0.003%)” NCT07277257 ↗ |
| Known as | ACO | “effectiveness of acoltremon ophthalmic solution 0.003% (ACO [Tryptyr®]), a recently approved treatment for DED signs and symptoms, on visual-tasking ADLs and WP.” PMID 42470519 ↗ Jul 2026 |
| Known as | AR-15512 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06660290 ↗ |
| Known as | AVX-012 | “The study part A will be an early safety assessment of AVX-012 ophthalmic solution (Low dose and High dose AVX-012) administered three times per day (TID) when compared with...” NCT03162094 ↗ |
| Known as | FEMA NO. 4681 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2441929 ↗ |
| Known as | Tryptyr | “Acoltremon 0.003% (TRYPTYR; Alcon Laboratories; Fort Worth, TX, USA) was recently approved by the US Food and Drug Administration (FDA) as the first transient receptor...” NCT07266948 ↗3“effectiveness of acoltremon ophthalmic solution 0.003% (ACO [Tryptyr®]), a recently approved treatment for DED signs and symptoms, on visual-tasking ADLs and WP.” PMID 42470519 ↗ Jul 2026 “TRYPTYR (Acoltremon 0.003%) is a newly FDA approved therapy for dry eye disease with a novel mechanism of action.” NCT07281950 ↗ |
| Known as | WS-12 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2441929 ↗ |
| Action | Activate | “transient receptor potential melastatin 8 agonist acoltremon” PMID 41038456 ↗ Sep 2025 |
| Modality | Small molecule | — CHEMBL2441929 ↗ |
| Route | Topical | “Ocular topical administration” NCT03162094 ↗ |
| Target | TRPM8 | “Acoltremon acts by activating TRPM8 receptors expressed on the neurons of the ophthalmic division of the trigeminal nerve” NCT07266948 ↗ |