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NOV05

NOV05 is a water-free ophthalmic solution of tacrolimus EyeSol® developed for the treatment of non-infectious anterior uveitis (NIAU).

Tacrolimus is an established immunomodulatory active ingredient; it inhibits calcineurin, a protein phosphatase essential for T-cell activation and cytokine production. But the molecular weight and the lipophilic nature made delivery to inner ocular tissues after topical administration challenging with classical water-based eye drop formulations.

Using the EyeSol® Technology, tacrolimus can be solubilized. NOV05 is a tacrolimus in perfluorobutylpentane solution. Perfluorobutylpentane is a known inactive ingredient in approved drugs like Vevye™ (NDA 217,469), Vevizye™ (EU/1/24/1857) and Heng Yi™. This proprietary vehicle has been shown to deliver tacrolimus to the iris and ciliary body at pharmacologically relevant concentrations.

The primary objective of multicenter phase 2 study (NCT07285070) is to investigate the safety and tolerability of NOV05 at two concentrations, administered topically as eyedrops, in subjects with active non-infectious anterior uveitis.

The secondary objective is to obtain clinical data of biological effect in patients with this condition.

Clinicaltrials.gov Identifier: NCT07285070

Publications

more information about the clinical trials.

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