Results of a post hoc analysis of data from the phase 3 Mont Blanc trial were reported at the 2025 American Glaucoma Society meeting in Washington, DC. The analysis found that a statistically significant greater proportion of eyes treated with NCX 470 (Nicox SA), an investigational nitric oxide (NO)–donating prostaglandin analog, achieved mean diurnal intraocular pressure (IOP) of ≤18 mmHg compared to latanoprost.
NCX 470 is designed to lower intraocular pressure (IOP) by combining the effects of bimatoprost with NO, which enhances aqueous humor outflow through the trabecular meshwork. It is being studied as a treatment for open-angle glaucoma and ocular hypertension.
Other post hoc findings from the Mont Blanc trial included the following:
- Greater mean percentage reduction in IOP was observed in NCX 470-treated eyes.
- In patients with a baseline IOP of ≤28 mmHg, NCX 470 demonstrated significantly greater IOP reduction than latanoprost at most time points measured.
- The IOP-lowering effect of NCX 470 was consistent across all baseline IOP levels, whereas latanoprost’s efficacy varied depending on initial IOP.
- A significantly higher proportion of patients on NCX 470 experienced an IOP reduction of more than 10 mmHg compared to latanoprost.
The Mont Blanc trial did not meet the prespecified secondary efficacy endpoint of statistical superiority over latanoprost in time-matched IOP change from baseline. However, NCX 470 was numerically superior at all time points and achieved statistical significance at four out of six time points.
NCX 470 is currently being evaluated in the pivotal phase 3 Denali trial and the phase 3b Whistler trial. The company expects to report results from both trials later in 2025. The company reports it hopes to file a New Drug Application with the US Food and Drug Administration in 2026. The drug is also being developed for the Chinese market in collaboration with Ocumension Therapeutics. GP
