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

Nicox, an international ophthalmology company, shared new data on their intraocular pressure (IOP)-lowering medication NCX 470 at the 2025 American Glaucoma Society (AGS) Annual Meeting this past weekend. The French company also shared developmental updates from the 470 Mont Blanc phase 3 clinical trial.

NCX 470 uses a dual mechanism of action — nitric oxide and a prostaglandin analog — to lower IOP. In this analysis, more patients on NCX 470 achieved an IOP of less than or equal to 18 mmHg compared to the standard of care, latanoprost. Additionally, the average reduction in IOP was significantly greater in patients using NCX 470 compared to latonoprost.

Additional findings from their poster presentation further suggest NCX 470 has key differnetiating factors from latonoprost. These include

• The IOP-lowering effect from baseline in eyes with an initial IOP of ≤ 28 mmHg was statistically significantly greater for NCX 470 compared to latanoprost at the majority of timepoints measured
• NCX 470 demonstrates a consistent lowering of IOP regardless of the baseline IOP, whereas the reduction in IOP with latanoprost is dependent on the baseline IOP
• A statistically significant greater proportion of patients who received NCX 470 showed an IOP reduction of greater than 10 mmHg from baseline, compared to those on latanoprost

“These data provide another example of where NCX 470 is differentiated from the standard-of-care for intraocular pressure reduction, latanoprost,” Doug Hubatsch, Chief Scientific Officer of Nicox, said in a recent press release. “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 full Mont Blanc data and publications of other analyses are available on Nicox’s website in the section Publications. 

The company stated that all developmental activities are on track, with U.S. New Drug Application submission targeted in H1 2026. Both the ongoing Whistler phase 3b clinical trial investigating NCX 470’s dual mechanism of action and the Denali phase 3 clinical trial evaluating NCX 470 in patients with open-angle glaucoma or ocular hypertension are expected to complete by the end of this year.