Regulatory Milestones and Clinical Development in Ophthalmology: The Case of NOV05

The FDA has cleared Novaliq's Investigational New Drug application for NOV05, a water-free tacrolimus ophthalmic solution in the EyeSol vehicle—authorizing clinical testing in non-infectious anterior uveitis and enabling evaluation of topical, steroid-sparing approaches for intraocular inflammation. Novaliq has stated aims to assess whether EyeSol can enable delivery to back-of-eye (posterior-segment) tissues.

The EYETAC trial is a randomized, double-masked Phase II study comparing two concentrations of the water-free tacrolimus ophthalmic solution. Planned to open at two U.S. clinical centers with an expected start in Q1 2026, it will enroll patients with active non-infectious anterior uveitis.

NOV05 is notable for delivering tacrolimus topically in a water-free EyeSol vehicle as a steroid-free option. Tacrolimus is an immunomodulator that may reduce T-cell–mediated inflammation; a topical, steroid-sparing approach could avoid steroid-associated risks such as intraocular pressure elevation and cataract progression.

The clinical rationale for a steroid-free topical is to control ocular inflammation promptly while reducing cumulative steroid exposure and its well-documented ocular sequelae. EYETAC will measure efficacy using objective inflammatory signs (anterior chamber cells and flare grading), validated symptom and vision-related patient-reported outcomes, predefined steroid-sparing metrics (frequency and cumulative dose of rescue corticosteroid use), and comprehensive safety monitoring including intraocular pressure and ocular adverse-event tracking—directly linking the steroid-sparing rationale to quantifiable trial endpoints.

Key Takeaways:

• NOV05 received FDA IND clearance, enabling the EYETAC Phase II evaluation in non-infectious anterior uveitis.
• EYETAC will test two concentrations of a water-free tacrolimus solution with steroid-sparing and safety endpoints at U.S. centers beginning Q1 2026.
• Positive EYETAC results could shift practice toward topical, steroid-sparing management options for intraocular inflammation.