Novaliq announced that the US Food and Drug Administration (FDA) has cleared its investigational new drug application for NOV05, a topical tacrolimus ophthalmic solution formulated in the company’s EyeSol drug delivery platform. The clearance allows initiation of the phase 2 EYETAC clinical trial in patients with noninfectious anterior uveitis.

NOV05 is Novaliq’s first IND cleared for an inner-eye indication. The investigational therapy is designed as a steroid-free topical anti-inflammatory treatment intended to deliver tacrolimus to uveal tissues. Although oral tacrolimus has demonstrated efficacy, its use is limited by systemic adverse effects and poor ocular bioavailability. Effective topical delivery of tacrolimus to intraocular tissues has not yet been established.

The EYETAC trial is a randomized, double-masked study to be conducted at US clinical centers and is expected to begin in the first quarter of 2026. The study will evaluate 2 concentrations of NOV05, focusing on safety, tolerability, and potential dose-dependent anti-inflammatory effects. The program is supported by prior pharmacokinetic, preclinical efficacy, and toxicology studies, the company said in a press release. RP