Tacrolimus Ophthalmic Solution for the Treatment of 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

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.

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.

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;