Novaliq announced that the FDA has cleared its investigational new drug (IND) application for NOV05.

The FDA clearance allows Novaliq to initiate EYETAC, a phase 2 clinical trial evaluating NOV05 in patients with noninfectious anterior uveitis (NIAU). The randomized, double-masked study is expected to begin in the first quarter of 2026 at clinical centers across the United States.

NOV05 is a tacrolimus ophthalmic solution formulated in Novaliq’s proprietary EyeSol technology, a water-free drug platform designed to enhance topical delivery to ocular tissues. Unlike current standard therapies, NOV05 is steroid-free, addressing an unmet need in uveitis care.

“FDA clearance of the EYETAC study is a major milestone in our strategic expansion into retinal and inner-eye diseases,” said Dr. Christian Roesky, Chief Executive Officer of Novaliq. “Patients with noninfectious anterior uveitis urgently need alternatives to corticosteroids. Our goal is to show that a topical, steroid-free eye drop can effectively control intraocular inflammation without the side effects associated with current treatments.”

According to Novaliq, today’s treatment options rely heavily on corticosteroid eye drops, with injections or systemic immunosuppressive drugs used in more severe cases—approaches that are often associated with complications such as elevated intraocular pressure, cataracts, and systemic side effects. While oral tacrolimus has shown efficacy, its use has been limited by low ocular bioavailability and systemic toxicity. NOV05 aims to overcome these limitations by delivering tacrolimus topically to the uveal tract.

The EYETAC phase 2 study (NCT #07285070) will evaluate two concentrations of NOV05 in patients with active NIAU. The trial’s primary objectives are to assess safety and tolerability, while exploratory endpoints will examine dose-dependent anti-inflammatory effects.

The study is supported by a preclinical data package, including ocular pharmacokinetic studies demonstrating delivery of tacrolimus to eye tissues following topical administration, efficacy shown in animal models of experimental uveitis, and successful toxicology studies.

In addition to its immediate clinical goals, EYETAC is designed to provide broader proof of concept for EyeSol-based topical delivery to inner- and back-of-the-eye tissues, potentially opening the door to a new generation of noninvasive retinal therapies.

Novaliq has already brought EyeSol technology to market with two FDA-approved products for dry eye disease, Miebo and Vevye, both of which are now available in the United States. The company believes the same platform can transform treatment paradigms beyond the ocular surface.