Nicox Announces New Data from NCX 470 Mont Blanc Trial, Provides Development Updates

Nicox, a global ophthalmology company, presented new data on its intraocular pressure (IOP)-lowering medication, NCX 470, at the 2025 American Glaucoma Society (AGS) Annual Meeting. The French company also provided updates on the NCX 470 Mont Blanc Phase 3 clinical trial, highlighting its superior performance over latanoprost, the current standard of care.

Key Findings from the NCX 470 Mont Blanc Trial

NCX 470 operates through a dual mechanism of action, combining nitric oxide and a prostaglandin analog to effectively reduce IOP. The latest analysis revealed several advantages over latanoprost:

       • A higher percentage of patients treated with NCX 470 achieved an IOP of ≤ 18 mmHg compared to those using latanoprost.

       • NCX 470 demonstrated a significantly greater average reduction in IOP.

       • The medication's IOP-lowering effect remained consistent regardless of baseline IOP, whereas latanoprost's effectiveness depended on baseline IOP.

       • A statistically significant higher proportion of patients receiving NCX 470 experienced an IOP reduction greater than 10 mmHg from baseline.

These findings, presented during the AGS meeting, reinforce the potential of NCX 470 as a differentiated treatment for glaucoma and ocular hypertension.

Development Updates and Future Plans

According to Doug Hubatsch, Chief Scientific Officer at Nicox, "These data provide another example of where NCX 470 is differentiated from the standard-of-care for intraocular pressure reduction, latanoprost. We also look forward to announcing the results of the Whistler trial, investigating the mechanism of action of NCX 470, shortly, and the second pivotal Phase 3 trial, Denali, in Q3 of this year."

The company confirmed that all developmental activities remain on schedule, with a U.S. New Drug Application (NDA) submission planned for the first half of 2026. The Whistler Phase 3b trial, which examines the dual mechanism of action of NCX 470, and the Denali Phase 3 trial, focused on patients with open-angle glaucoma or ocular hypertension, are expected to conclude by the end of 2025.

Industry Impact

If approved, NCX 470 could significantly improve treatment outcomes for patients with glaucoma and ocular hypertension. Its ability to provide consistent and superior IOP reduction compared to current therapies underscores its potential as a leading therapeutic option in the ophthalmology space.