Tryptyr (acoltremon ophthalmic solution) / Alcon - LARVOL DELTA

Disproportionality analyses of acoltremon: a real-world safety assessment based on the the FDA adverse event reporting system database. (PubMed, Front Med (Lausanne)) - "This study identified potential safety signals associated with acoltremon in the FAERS database. These findings should be interpreted cautiously and warrant further pharmacovigilance and clinical investigation."

Adverse events • Journal • Real-world evidence • Dermatology • Dry Eye Disease • Herpes Simplex • Immunology • Infectious Disease • Ophthalmology • Pain • Pruritus • Respiratory Diseases

Long-term Effects of Acoltremon vs. Control in Dry Eye Disease (clinicaltrials.gov) - P=N/A | N=60 | Recruiting | Sponsor: The Eye Care Institute | Not yet recruiting ➔ Recruiting

Enrollment open • Dry Eye Disease • Ophthalmology

TRYPTYR as a Treatment for Patients With Dry Eye Disease (DED) (clinicaltrials.gov) - P4 | N=50 | Recruiting | Sponsor: NYU Langone Health

New P4 trial • Dry Eye Disease • Ophthalmology

Improvement in Visual-Tasking Daily Living Activities and Work Productivity in Patients with Dry Eye Disease: Integrated Analysis of COMET Studies. (PubMed, Ophthalmol Ther) - P2, P3 | "These exploratory data suggest that ACO is associated with rapid and sustained improvements in visual-tasking ADLs and WP."

Journal • Dry Eye Disease • Ophthalmology

Crystal structure of the (1R,2S,5R) diastereomer of acoltremon, C18H27NO2, from synchrotron powder diffraction data and density functional theory calculations. (PubMed, Acta Crystallogr E Crystallogr Commun) - "Acoltremon crystallizes in space group P212121 and the crystal structure consists of corrugated layers lying parallel to the bc plane. N-H⋯O hydrogen bonds link the mol-ecules into chains propagating along the a-axis direction, with graph-set descriptor C 1 1(4)."

Journal

The Neuro-Immune-Epithelial Axis in Dry Eye: From Pathogenic Crosstalk to Neuromodulatory Therapies. (PubMed, Exp Eye Res) - "Varenicline nasal spray and acoltremon engage reflex or sensory tear pathways where approved; motugivatrep illustrates region-specific TRPV1 translation in Japan; diquafosol and rebamipide are epithelial/mucin-supportive therapies with indirect axis relevance; and cenegermin remains primarily a neurotrophic keratitis therapy with restricted relevance to selected DED phenotypes. Neuropeptide-specific targets, availability-limited device stimulation, and direct nerve-regenerative claims for photobiomodulation remain preliminary. This framework may support mechanism-based stratification and rational adjunctive therapy without replacing established DED classifications."

Journal • Review • Dry Eye Disease • Immunology • Inflammation • Keratitis • Ocular Inflammation • Ophthalmology • Pain • TRPV1

Long-term Effects of Acoltremon vs. Control in Dry Eye Disease (clinicaltrials.gov) - P=N/A | N=60 | Not yet recruiting | Sponsor: The Eye Care Institute

New trial • Dry Eye Disease • Ophthalmology

Matching-adjusted indirect comparison of acoltremon ophthalmic solution 0.003% and cyclosporine 0.05% ophthalmic emulsion for increased tear production in patients with dry eye disease. (PubMed, J Comp Eff Res) - " Our findings suggest that acoltremon 0.003% may provide a greater increase in tear production relative to cyclosporine 0,05% at day 90, with exploratory findings suggesting similar results at day 14. As this was an unanchored MAIC, results may be influenced by residual confounding from unmeasured differences between trials."

Journal • Anesthesia • Dry Eye Disease • Ophthalmology

Tear Production Stimulated by Acoltremon 0.003% is Negligibly Influenced By Instillation Site Sensation (ARVO 2026) - "The mediation analysis results further demonstrated that ISS plays a negligible role in ACO total tear production. These findings are consistent with ACO's proposed mechanism of TRPM8 receptor stimulation leading to activation of the trigeminal nerve to increase natural tear production."

Dry Eye Disease • Ophthalmology • TRPM8

Acoltremon 0.003% for Dry Eye Disease: Placing the Phase 3 Results in Perspective. (PubMed, Ophthalmology) - No abstract available

Journal • P3 data • Dry Eye Disease • Ophthalmology

Effect of Acoltremon Ophthalmic Solution 0.003% on Signs and Symptoms of Ocular Surface Disease in Stage I Neurotrophic Keratopathy Patients With Tear Deficiency (clinicaltrials.gov) - P4 | N=50 | Recruiting | Sponsor: University of South Florida

New P4 trial • Dry Eye Disease • Ophthalmology

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