Nicox SA provided details of a poster presentation highlighting additional pre-planned analysis from the NCX 470 Mont Blanc phase 3 clinical trial at the 2025 American Glaucoma Society (AGS) Annual Meeting, one of the key scientific events in vision research, which was held on Feb. 26 to March 2, 2025 in Washington, United States.
The company also provided an update on NCX 470 development.
“These data provide another example of where NCX 470 is differentiated from the standard-of-care for intraocular pressure reduction, latanoprost. In this analysis, we demonstrated that more patients achieve intraocular pressure of less than or equal to 18 mmHg on NCX 470 than on latanoprost. In addition, the mean percentage reduction in intraocular pressure was greater in patients on NCX 470 compared to those on latanoprost.” said Doug Hubatsch, chief scientific officer of Nicox. “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.”
Poster Title: Diurnal Intraocular Pressure Control Responder Analysis with NCX 470 Versus Latanoprost in the Phase 3 MONT BLANC Trial
A statistically significant greater proportion of eyes treated with NCX 470 0.1% achieved mean diurnal IOPs of ≤18 mmHg compared to those in the latanoprost 0.005% group in this analysis of the multinational phase 3 Mont Blanc clinical trial.
Additionally, greater mean percent IOP reductions from baseline were seen in the eyes treated with NCX 470 than in eyes treated with latanoprost.
Summary of key differentiating factors seen in post hoc analysis of Mont Blanc
- Statistically significant percentage of patients achieve ≤ 18mmHg IOP on NCX 470 compared to latanoprost
- Mean percentage reduction in IOP greater on NCX 470 than on latanoprost
- In eyes with an initial IOP of ≤ 28 mmHg the IOP-lowering effect from baseline 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
The Mont Blanc trial demonstrated that NCX 470 met the efficacy standard for approval in the United States, non-inferiority to latanoprost, with an IOP reduction of 8.0 to 9.7 mmHg.
While NCX 470 failed to meet statistical superiority to latanoprost in a pre-specified secondary efficacy analysis of time-matched change from baseline IOP, NCX 470 was numerically superior to latanoprost at all time points and statistically significant (p<0.049) at 4 of 6 timepoints.
The full Mont Blanc data and publications of other analyses are available on Nicox’s website in the section Publications.
Update on NCX 470 development
In addition to the Denali clinical trial, other development activities to support the preparation of a New Drug Application in the U.S. and China, where NCX 470 is partnered with Ocumension Therapeutics, are ongoing.
These include supporting clinical and non-clinical trials and pharmaceutical development.
Assuming a partnership for the U.S. or obtaining appropriate financing, the company believes these activities are on track to allow an NDA filing in S1 2026, supporting potential launch in the U.S. in S1 2027.
The last patient in the ongoing Whistler phase 3b clinical trial investigating NCX 470’s dual mechanism of action (nitric oxide and prostaglandin analog) in IOP lowering is now expected to complete the study late in the first of 2025, and therefore the results are now expected in mid-second quarter of 2025, compared to the previous estimate of first quarter.
The Denali phase 3 clinical trial evaluating NCX 470 in patients with open-angle glaucoma or ocular hypertension remains on track with all patients recruited and topline results are expected in the third quarter 2025.