Tryptyr (acoltremon ophthalmic solution) / Alcon - LARVOL DELTA

Novel drugs approved by the EMA, the FDA and the MHRA in 2025: A year in review. (PubMed, Br J Pharmacol) - "Among the FIC drugs, it is worth mentioning the Nav1.8 channel inhibitor suzetrigine, the first non-opioid approved to palliate acute pain; the first positive allosteric modulator of transient receptor potential melastatin 8 (TRPM8), acoltremon, that increases basal tear production in dry eye disease, a globally common disorder; lerodalcibep, a 'third generation' adnectin inhibitor of the protease Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) to treat elevated LDL-c; and zoliflodacin and gepotidacin, both innovatively targeting bacterial topoisomerases to treat uncomplicated urinary tract infections. These approaches include: the combination of two FIC drugs, the RAF/MEK clamp avutometinib paired with the FAK/Pyk2 inhibitor defactinib, to block more efficiently the RAS-RAF-MEK-ERK/FAK oncogenic pathway in low-grade serous ovarian cancer; fitusiran, the first RNAi therapy for haemophilia, targeting for the first time the production of the natural..."

European regulatory • FDA event • Journal • Review • Bronchiectasis • Dry Eye Disease • Hematological Disorders • Hemophilia • Infectious Disease • Nephrology • Oncology • Ophthalmology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pain • Pulmonary Disease • Rare Diseases • Respiratory Diseases • Solid Tumor • NAV1 • TRPM8

Developments in the therapeutic landscape for dry eye. (PubMed, Expert Opin Pharmacother) - "Integrating targeted therapies, device-based interventions, and regenerative approaches with improved diagnostics may enable more predictable, proactive care. Rigorous research is still needed to optimize treatment selection and sequencing."

Journal • Review • Dry Eye Disease • Inflammation • Ocular Inflammation • Ophthalmology

The Drug Update: Recent drug approvals, winter 2026 edition. (PubMed, Nurse Pract) - "This article highlights the following new medications and vaccinations: suzetrigine (Journavx); gepotidacin (Blujepa); meningococcal groups A, B, C, W, and Y vaccine (Penmenvy); clesrovimab-cfor (Enflonsia); and acoltremon (Tryptyr). Additionally, this article highlights the recent approval of moderately to severely active Crohn's disease as a new indication for guselkumab (Tremfya)."

Journal • CNS Disorders • Crohn's disease • Dry Eye Disease • Gastroenterology • Immunology • Infectious Disease • Inflammatory Bowel Disease • Meningococcal Infections • Nephrology • Ophthalmology • Pain • Respiratory Diseases • Respiratory Syncytial Virus Infections

Investigator Initiated Trial Using Dry Eye Surveys to Evaluate and Better Understand FDA Approved Acoltremon Treatment for Dry Eye Disease in Real World Treatment Settings (DESERT) (clinicaltrials.gov) - P4 | N=60 | Not yet recruiting | Sponsor: Center for Sight Las Vegas

HEOR • New P4 trial • Real-world evidence • Dry Eye Disease • Ophthalmology

Evaluating a New Therapy for Dry Eye in Patients With Sjögren's Syndrome (clinicaltrials.gov) - P4 | N=35 | Recruiting | Sponsor: Center For Sight

New P4 trial • Conjunctivitis • Dry Eye Disease • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology • Sjogren's Syndrome

"Acoltremon: a novel advancement in dry eye disease management". (PubMed, Ann Med Surg (Lond)) - No abstract available

Journal • Dry Eye Disease • Ophthalmology

ASTRA: Moderate-to-Severe Dry Eye Disease Relief Using Acoltremon (clinicaltrials.gov) - P=N/A | N=50 | Enrolling by invitation | Sponsor: Colvard Kandavel Eye Center

New trial • Dry Eye Disease • Ophthalmology

Switching From Xiidra to TRYPTYR (clinicaltrials.gov) - P4 | N=100 | Not yet recruiting | Sponsor: Southern College of Optometry

New P4 trial • Dry Eye Disease • Ophthalmology

TRYPTYR ADL: Impact of TRYPTYR on a Patient's Quality of Life and Ability to Perform Work (clinicaltrials.gov) - P4 | N=40 | Recruiting | Sponsor: Southern College of Optometry

HEOR • New P4 trial • Dry Eye Disease • Ophthalmology

Switching From Restasis to TRYPTYR (clinicaltrials.gov) - P4 | N=100 | Not yet recruiting | Sponsor: Southern College of Optometry

New P4 trial • Dry Eye Disease • Ophthalmology

Acoltremon and the TRPM8 frontier: a new chapter in dry eye disease therapy. (PubMed, Ann Med Surg (Lond)) - No abstract available

Journal • Dry Eye Disease • Ophthalmology • TRPM8

Acoltremon Ophthalmic Solution 0.003% for Signs and Symptoms of Dry Eye Disease: Results of Phase 3 Pivotal Studies COMET-2 and COMET-3. (PubMed, Ophthalmology) - P3 | "In both phase 3 studies, ACO compared with VEH led to consistent, clinically meaningful tear production as well as reductions in other DED signs and symptoms."

Journal • P3 data • Anesthesia • Dry Eye Disease • Ophthalmology

Acoltremon (Tryptyr) for dry eye disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Dry Eye Disease • Ophthalmology

Current and emerging pharmacological treatment options for patients with dry eye disease. (PubMed, Expert Rev Clin Pharmacol) - "The recent FDA approval of AR-15512, a TRPM8 agonist, exemplifies the trend toward mechanism-specific therapies designed to deliver both symptomatic relief and disease modification. As the therapeutic armamentarium expands globally, continued clinical trials and real-world studies will be essential to ensure durable efficacy and optimize patient outcomes."

Journal • Review • Dry Eye Disease • Inflammation • Ocular Inflammation • Ophthalmology • TRPM8

Acoltremon: First Approval. (PubMed, Drugs) - "During phase III trials in patients with dry eye disease, acoltremon demonstrated increased tear production with a low treatment discontinuation rate. This article summarizes the milestones in the development of acoltremon leading to this first approval for the treatment of the signs and symptoms of dry eye disease."

Journal • Dry Eye Disease • Ophthalmology • TRPM8

Acoltremon. (PubMed, Am J Health Syst Pharm) - No abstract available

Journal

Acoltremon: The first TRPM8 agonist approved for the treatment of dry eye disease. (PubMed, Drug Discov Ther) - "Acoltremon has multiple advantages: rapid onset of action, significant alleviation of dry eye signs and symptoms, and favorable safety and tolerability. In summary, the approval of acoltremon represents a new therapeutic perspective on the management of DED."

Journal • Dry Eye Disease • Ophthalmology • Pain • TRPM8

Alcon Announces FDA Approval of TRYPTYR (acoltremon ophthalmic solution) 0.003% for the Treatment of the Signs and Symptoms of Dry Eye Disease (Businesswire) - "Alcon...announced the U.S. Food and Drug Administration (FDA) has approved TRYPTYR (acoltremon ophthalmic solution) 0.003%, formerly known as AR-15512, for the treatment of signs and symptoms of Dry Eye Disease (DED)....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. 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)."

FDA approval • Dry Eye Disease

Tear production with the novel TRPM8 agonist acoltremon: a phase 1 methodology study (ARVO 2025) - "Acoltremon (previously AR-15512) is a potent and highly selective TRPM8 agonist in development as a treatment option for dry eye disease (DED)...The most common adverse event in the study was mild instillation site burning/stinging, reported by 20% of subjects receiving acoltremon. These findings are consistent with the mechanism of acoltremon as an activator of the TRPM8 receptor, and suggest that future clinical studies with acoltremon are best performed in a real-world setting in the absence of topical anesthetic."

P1 data • Dry Eye Disease • Ophthalmology • TRPM8

A Study to Investigate the Effect of 0.003% AR-15512 on Subjects With Dry Eye Disease (clinicaltrials.gov) - P3 | N=79 | Completed | Sponsor: Alcon Research | Active, not recruiting ➔ Completed

Trial completion • Dry Eye Disease • Ophthalmology

A Study to Evaluate 0.003% AR-15512 Safety and Drop Attributes (clinicaltrials.gov) - P3 | N=55 | Completed | Sponsor: Alcon Research | Recruiting ➔ Completed

Trial completion • Dry Eye Disease • Ophthalmology

A Study Designed to Evaluate Tear Production (clinicaltrials.gov) - P3 | N=81 | Completed | Sponsor: Alcon Research | Recruiting ➔ Completed

Trial completion • Dry Eye Disease • Ophthalmology

A Study to Investigate the Effect of 0.003% AR-15512 on Subjects With Dry Eye Disease (clinicaltrials.gov) - P3 | N=79 | Active, not recruiting | Sponsor: Alcon Research | Recruiting ➔ Active, not recruiting

Enrollment closed • Dry Eye Disease • Ophthalmology

A Study to Evaluate 0.003% AR-15512 Safety and Drop Attributes (clinicaltrials.gov) - P3 | N=55 | Recruiting | Sponsor: Alcon Research | Not yet recruiting ➔ Recruiting

Enrollment open • Dry Eye Disease • Ophthalmology

A Study to Evaluate 0.003% AR-15512 Safety and Drop Attributes (clinicaltrials.gov) - P3 | N=55 | Not yet recruiting | Sponsor: Alcon Research

New P3 trial • Dry Eye Disease • Ophthalmology