August 22, 2025
1 min read
Key takeaways:
- The eye drop achieved noninferiority in lowering IOP vs. latanoprost.
- Nicox plans to submit a new drug application for NCX 470 0.1% to the FDA in 2026.
Editor’s note: This is a developing news story. Please check back soon for updates.
NCX 470 0.1%, a novel nitric oxide-donating bimatoprost eye drop, achieved its primary endpoint in the phase 3 Denali clinical trial, according to a press release from Nicox.

NCX 470 achieved noninferiority in lowering IOP vs. latanoprost.
The randomized, multiregional, double-masked, parallel group trial enrolled 696 patients with open-angle glaucoma or ocular hypertension at 90 sites in the U.S. and China. Efficacy and safety of NCX 470 were compared with latanoprost ophthalmic solution 0.005%, the standard of care. The primary endpoint was noninferiority of NCX 470 in lowering IOP.
From baseline, the IOP-lowering effect was 7.9 mm Hg to 10 mm Hg for NCX 470 vs. 7.1 mm Hg to 9.8 mm Hg for latanoprost at time-matched visits. IOP reductions for NCX 470 compared with latanoprost were numerically greater at five out of six timepoints and statistically superior at three out of six timepoints (P < .05); “however, overall statistical superiority was not achieved” for this prespecified secondary efficacy endpoint, the release said.
The most common adverse event was conjunctival hyperemia (22% of patients with NCX 470 vs. 9.2% of patients with latanoprost). No ocular serious adverse events were reported.
As Healio previously reported, NCX 470 achieved noninferiority compared with latanoprost in lowering IOP in the phase 3 Mont Blanc clinical trial.
Nicox plans to submit a new drug application for NCX 470 0.1% to the FDA in 2026.
“With a second phase 3 trial demonstrating the necessary efficacy and safety profile for submission of new drug applications … in both the United States and China, we are now moving forward toward potential recurrent NCX 470 royalty revenue from 2027 onward,” Gavin Spencer, CEO of Nicox, said in the release. “Our established partnerships with Kowa and Ocumension enable us to accelerate NDA preparations, whilst also allowing us to focus on potential future strategies for the company.”