Nicox Achieves Milestone in NCX 470 Phase 3 Clinical Trial

Nicox SA has announced the completion of the Denali Phase 3 clinical trial for NCX 470, involving 696 patients with open-angle glaucoma or ocular hypertension. The trial marks a significant achievement for the company, with topline results anticipated by mid-August to mid-September 2025. This milestone is crucial for the planned New Drug Application (NDA) submission in the U.S., expected in the first half of 2026, contingent upon securing a U.S. partner or necessary funding.

NCX 470 is a novel NO-donating bimatoprost eye drop, developed to lower intraocular pressure. The trial evaluates its efficacy against latanoprost ophthalmic solution. The international trial, conducted in the U.S. and China, is jointly financed by Nicox and Ocumension.

Moving forward, Nicox plans to initiate NCX 470's Phase 3 trials in Japan in the latter half of 2025. The results of these trials will further define NCX 470's potential in the global glaucoma market.