Nicox Publishes Adaptive Design Results for NCX 470 Phase 3 Trial

Nicox SA has announced the publication of results from the adaptive design period of its NCX 470 Mont Blanc Phase 3 trial. This trial assessed the efficacy and safety of NCX 470 in treating patients with open-angle glaucoma or ocular hypertension. Two concentrations of NCX 470, 0.065% and 0.1%, were tested, both outperforming the comparator, latanoprost 0.005%. Based on effectiveness in reducing intraocular pressure and safety, the 0.1% concentration was selected for further trials.

At two weeks, the 0.065% group showed a mean IOP reduction of 1.51 mmHg, while the 0.1% had a reduction of 1.71 mmHg compared to latanoprost. Conjunctival/ocular hyperemia was the most common side effect, with similar incidence across both NCX 470 doses. The Mont Blanc trial’s adaptive period replaced further dose-ranging studies, advancing the 0.1% concentration. The ongoing Denali trial will also utilize this concentration, with results anticipated in the third quarter of 2025.