Nicox SA announced the company completed the additional preplanned analyses of the NCX 470 Denali phase 3 clinical trial data. According to a company press release, these analyses confirm an efficacy profile similar to that seen in the subgroup analysis of the Mont Blanc trial.

In addition, reduction in intraocular pressure (IOP) was measured in the long-term safety extension period of the Denali trial from 6 months through to 12 months. According to the company, NCX 470 maintained robust IOP reduction during this period with no additional safety signals seen. 

Nicox said new drug applications (NDAs) for NCX 470 are in preparation for the United States and China—with the NDA submission in the US expected in the first half of 2026, and the NDA submission in China expected shortly after submission in the US. The NCX 470 phase 3 clinical program in Japan was initiated in summer 2025. 

The company said it plans to publish further data at upcoming ophthalmology conferences. 

Denali is a randomized, multi-regional, double-masked, parallel group trial that evaluated the safety and efficacy of NCX 470 ophthalmic solution, 0.1% compared to latanoprost ophthalmic solution, 0.005% in 696 patients in 90 sites in the US and China. The primary efficacy evaluation was based on reduction from baseline in mean time-matched IOP at 6 time points: 8 am and 4 pm at week 2, week 6 and month 3. The Denali trial also included a long-term safety extension from 6 months through to 12 months, the company said.