Tacrolimus Ophthalmic Solution for the Treatment of Non-infectious Anterior Uveitis (EYETAC)

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

The primary objective of the study is to investigate the safety and tolerability of NOV05 eye drops at two concentrations QID in patients with active non-infectious anterior uveitis.

Study Overview

• Status: Recruiting
• Conditions: Non-infectious Anterior Uveitis
• Intervention / Treatment: Drug: Tacrolimus ophthalmic solution

Detailed Description

This first in-human, phase 2 proof of concept study aims to show that the formulation at two concentrations is safe and well tolerated over a period of 6 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Alice Meides, PhD; Phone Number: +49 622150259; Email: ameides@novaliq.com

Study Locations

• United States
  • Massachusetts
    • Waltham, Massachusetts, United States, 02451
      • Recruiting
      • Massachusetts Eye Research and Surgery Institution
      • Contact: Megan Mitchell; Phone Number: 402 +1 781-647-1431
  • New Jersey
    • Palisades Park, New Jersey, United States, 07650
      • Recruiting
      • Metropolitan Eye Research and Surgery Institute
      • Contact: Sachi Desai; Phone Number: 125 +1 201-461-3970
  • Texas
    • McAllen, Texas, United States, 78503
      • Recruiting
      • Valley Retina Institute, P.A.
      • Contact: Alexia Salas; Phone Number: 1802 +1 956-631-8875
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Recruiting
      • Virginia Eye Consultants
      • Contact: Alexandria Robinson; Phone Number: +1 757-493-3053

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tacrolimus ophthalmic solution (high dose)	Drug: Tacrolimus ophthalmic solution; high and low dose treatment will be compared over 6 weeks treatment
Active Comparator: Tacrolimus ophthalmic solution (low dose)	Drug: Tacrolimus ophthalmic solution; high and low dose treatment will be compared over 6 weeks treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	ocular and non-ocular adverse events	8 weeks

Collaborators and Investigators

• Sponsor: Novaliq GmbH
• Investigators: Study Director: Sonja Kroesser, PhD, Novaliq GmbH

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: NOV05-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No