Tacrolimus eye drops for adults with active non-infectious anterior uveitis

A Phase 2, Randomized, Double-Masked, Controlled, Proof-of-Concept Study to Evaluate the Safety and Biological Activity of a Water-free Tacrolimus Ophthalmic Solution (NOV05) for the Treatment of Non-Infectious Anterior Uveitis

This study will try two strengths of tacrolimus eye drops given four times daily for six weeks to see if they are safe and well tolerated in adults with active non-infectious anterior uveitis.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Novaliq GmbH (industry)
• Locations: 4 sites (Waltham, Massachusetts and 3 other locations)
• Trial ID: NCT07285070 on ClinicalTrials.gov

What this trial studies

This first-in-human, phase 2 proof-of-concept trial tests a semifluorinated-alkane formulation of tacrolimus ophthalmic solution at two concentrations administered QID for six weeks, with safety and tolerability as the primary endpoints. Eligible adults have active non-infectious anterior uveitis requiring initiation or an increase of topical steroid therapy and symptom onset within 4 weeks. The study is multicenter and conducted at ophthalmology research clinics in the United States, with regular in-person visits for safety assessments. Exploratory observations may also track changes in ocular inflammation over the treatment period.

Who should consider this trial

Good fit: Adults aged 18 or older with active non-infectious anterior uveitis who need to start or increase topical steroid treatment and whose symptoms began within the past four weeks.

Not a fit: People with infectious uveitis, active intermediate or posterior uveitis, severe ocular pathology in the study eye, known allergy to tacrolimus or semifluorinated alkanes, or who are pregnant or nursing are unlikely to be eligible or to benefit from this trial.

Why it matters

Potential benefit: If successful, the drops could provide a topical, steroid-sparing anti-inflammatory option that controls anterior uveitis with fewer steroid-related side effects.

How similar studies have performed: Tacrolimus and other calcineurin inhibitors have shown benefit in ocular inflammatory and surface conditions in other formulations, but this specific semifluorinated-alkane tacrolimus eye drop formulation is novel and is being tested in humans for the first time.

Eligibility criteria

Inclusion Criteria:

* Be ≥18 years of age;
* Provide written informed consent;
* Be diagnosed with active non-infectious anterior uveitis requiring initiation or increase of topical steroids administration for the management of ocular inflammation;
* Have an onset of symptoms within 4 weeks;

Exclusion Criteria:

* Have severe/serious ocular pathology in the study eye which may preclude study completion or interferes with trial assessment, in the judgement of the clinical Investigator;
* Have a history of or a current ocular or periocular malignancy;
* Have active intermediate or posterior uveitis in the study eye or another documented posterior segment inflammation;
* A confirmed or highly suspicious infectious uveitis eg, CMV, Herpes simplex, Herpes zoster, syphilis, tuberculosis, lyme disease;
* Have a known allergy or sensitivity to the IMP tacrolimus or semifluorinated alkanes (SFA);
* Be a woman who is pregnant, nursing, or planning a pregnancy;
* Have a condition or be in a situation (e.g. language barrier, non-cooperative, history of substance abuse) which the Investigator considers that it may put the patient at significant risk, may confound the trial results, or may significantly interfere with the patient's participation in the trial;

Where this trial is running

Waltham, Massachusetts and 3 other locations

• Massachusetts Eye Research and Surgery Institution — Waltham, Massachusetts, United States (RECRUITING)
• Metropolitan Eye Research and Surgery Institute — Palisades Park, New Jersey, United States (RECRUITING)
• Valley Retina Institute, P.A. — McAllen, Texas, United States (RECRUITING)
• Virginia Eye Consultants — Norfolk, Virginia, United States (RECRUITING)

Study contacts

• Study coordinator: Alice Meides, PhD

Conditions: Non-infectious Anterior Uveitis