Licaminlimab eye drops for dry eye disease in people with a specific genotype

A Phase 2b/3, Double-masked, Randomized, Vehicle-controlled, Multicenter Study Evaluating Licaminlimab in Dry Eye Disease Patients With a Specific TNFR1 Genotype

This trial will test whether licaminlimab eye drops help people with dry eye disease who have a particular genotype, compared with inactive drops.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Oculis (industry)
• Drugs / interventions: licaminlimab
• Locations: 10 sites (Glendale, California and 9 other locations)
• Trial ID: NCT07548632 on ClinicalTrials.gov

What this trial studies

Participants with a recent physician diagnosis of dry eye who use over-the-counter tears will be genotyped and, if eligible, randomized after an artificial tear run-in to receive topical licaminlimab or vehicle. The program includes Phase 2 and Phase 3 cohorts and compares signs, symptoms, and safety outcomes between the active drug and vehicle. Dosing is by ophthalmic administration and investigators will monitor ocular and systemic adverse events along with measures of dry eye severity. Study visits take place at specialized ophthalmology sites in the United States.

Who should consider this trial

Good fit: Ideal candidates are adults with a physician diagnosis of dry eye disease within the past six months who regularly use over-the-counter tears and are willing to undergo genotype testing and site visits.

Not a fit: Patients who do not carry the specific genotype, who have other eye conditions that could confound results, or who have medical issues the investigator believes would interfere are unlikely to benefit from this genotype-targeted approach.

Why it matters

Potential benefit: If successful, licaminlimab could reduce ocular inflammation and improve dry eye symptoms for patients who carry the targeted genotype.

How similar studies have performed: Genotype-guided topical biologic treatment for dry eye is relatively novel, and early-phase data for licaminlimab are limited but have supported progression to larger randomized testing.

Eligibility criteria

Key Inclusion Criteria:

* Physician diagnosis of Dry Eye Disease in the past 6 months
* Use of over-the-counter tears
* Must agree to genotype testing

Key Exclusion Criteria:

\- Have a history or presence of any disorder or condition that may, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety.

Where this trial is running

Glendale, California and 9 other locations

• Global Research Management — Glendale, California, United States (RECRUITING)
• Eye Research Foundation — Newport Beach, California, United States (RECRUITING)
• Vision Institute — Colorado Springs, Colorado, United States (RECRUITING)
• Segal Drug Trials, Inc. — Delray Beach, Florida, United States (NOT_YET_RECRUITING)
• Oculus Research, Inc. — Garner, North Carolina, United States (RECRUITING)
• CORE, Inc — Shelby, North Carolina, United States (NOT_YET_RECRUITING)
• Scott & Christie and Associates — Cranberry Township, Pennsylvania, United States (RECRUITING)
• Erie Retina Research — Erie, Pennsylvania, United States (NOT_YET_RECRUITING)
• Total Eye Care, PA — Memphis, Tennessee, United States (RECRUITING)
• Piedmont Eye Center, Inc. — Lynchburg, Virginia, United States (RECRUITING)

Study contacts

• Study coordinator: Oculis Chief Development Officer

Conditions: Dry Eye Disease, licaminlimab, OCS-02, PREDICT-1, genotype based development, Eye drops