CAMBRIDGE, Mass. — Novaliq, a biopharmaceutical company developing ocular therapeutics based on its water-free EyeSol® drug technology, said the U.S. Food and Drug Administration has cleared its Investigational New Drug application for NOV05, enabling the start of a Phase II clinical trial in patients with non-infectious anterior uveitis.
The clearance marks Novaliq’s first IND for an inner-eye indication and allows initiation of the EYETAC Phase II study evaluating NOV05, a tacrolimus ophthalmic solution formulated in EyeSol®. NOV05 is designed as a steroid-free topical anti-inflammatory therapy for non-infectious anterior uveitis, an inner-eye inflammatory disease that can lead to vision loss if not treated effectively.
Non-infectious anterior uveitis involves inflammation of the iris and ciliary body and commonly presents with eye redness, pain, and light sensitivity. In the developed world, the condition accounts for an estimated 67% to 90% of uveitis cases. Current treatments are largely limited to corticosteroid eye drops, periocular or intraocular steroid injections, or systemic immunosuppressive therapies, all of which are associated with well-documented complications.
While oral tacrolimus has demonstrated efficacy in uveitis, its use has been limited by low bioavailability in ocular tissues and systemic side effects. To date, effective delivery of topical tacrolimus to inner-eye tissues has not been demonstrated.
“The IND clearance of the EYETAC study is a major milestone in our strategic expansion into retina and inner-eye diseases using targeted topical delivery of EyeSol®-based drugs,” said Dr. Christian Roesky, Chief Executive Officer of Novaliq. “A steroid-free eye drop that effectively controls intraocular inflammation without associated side effects represents a significant unmet medical need for patients with non-infectious anterior uveitis and could be addressed with NOV05. In addition, this study is intended to provide proof of delivery of active ingredients to tissues at the back of the eye using EyeSol®, which would enable development of multiple topical therapies for retinal diseases.”
The EYETAC study is a Phase II, randomized, double-masked clinical trial to be conducted at clinical sites in the United States in patients with active non-infectious anterior uveitis. The trial will evaluate two concentrations of tacrolimus and is expected to begin in the first quarter of 2026. The study is designed to assess the safety and tolerability of NOV05 and to explore its potential dose-dependent anti-inflammatory effects.
The clinical program builds on prior ocular pharmacokinetic studies demonstrating delivery of tacrolimus to ocular tissues following topical administration, pharmacological effects observed in animal models of experimental uveitis, and supportive toxicology findings.
