FDA clears Novaliq’s Investigational New Drug application for NOV05

The US Food and Drug Administration (FDA) has cleared Novaliq’s Investigational New Drug (IND) application for NOV05, enabling the initiation of the EYETAC phase II clinical trial (NCT07285070) in patients with non-infectious anterior uveitis (NIAU).

NOV05, tacrolimus ophthalmic solution in EyeSol, is a unique, steroid-free topical anti-inflammatory treatment.

Christian Roesky, MD, PhD, CEO of Novaliq, commented on the FDA clearance, saying, “The IND clearance of the EYETAC study is a major milestone on our strategic expansion to retina and diseases of the inner eye using targeted topical delivery of EyeSol-based drugs. A steroid-free eye drop that effectively controls intraocular inflammation, without associated side effects, is an unmet medical need currently in patients with NIAU and that could be addressed with NOV05. Furthermore, the study aims to demonstrate a general proof of delivery of active ingredients to the back of the eye tissues using EyeSol, which would allow us to develop multiple topical EyeSol therapies for retina diseases.”

EYETAC is a phase 2, randomized, double-masked clinical trial conducted across 2 clinical centers in the US. It will be evaluating 2 concentrations of water-free tacrolimus ophthalmic solution (NOV05) for the treatment of non-infectious anterior uveitis. According to the company, the trial is expected to begin in Q1 of 2026.

The company also noted that the clinical study is based on prior ocular pharmacokinetics findings demonstrating delivery of tacrolimus to ocular tissues after topical application in 2 species, the demonstration of pharmacological effect in 2 independent animal models of experimental uveitis, and the successful toxicology study.

Anterior uveitis is an inflammation of the inner eye, including the iris and ciliary body, that typically causes a red, painful, light‑sensitive eye and can lead to vision loss if not treated promptly. NIAU represents 67-90% of uveitis cases in the developed world, according to the company.

Reference:

1. Novaliq Receives FDA IND Clearance to Advance NOV05 in a Phase II Clinical Trial in Non-infectious Anterior Uveitis. Published January 26, 2026. Accessed January 26, 2026. https://www.businesswire.com/news/home/20260126710784/en/Novaliq-Receives-FDA-IND-Clearance-to-Advance-NOV05-in-a-Phase-II-Clinical-Trial-in-Non-infectious-Anterior-Uveitis