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# Nicox Plans NDA for Glaucoma Drug
- URL: https://www.fdaweb.com/nicox-plans-nda-for-glaucoma-drug/
- Published: 2025-08-21T12:00:00.000Z
- Updated: 2026-09-14T15:19:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159731

Nicox says it will submit an NDA early next year after new data from its DENALI Phase 3 study of glaucoma therapy NCX 470 showed promising results. The study, which enrolled 696 patients with open-angle glaucoma or ocular hypertension across 90 sites in the U.S. and China, showed that once-daily NCX 470 0.1% eye drops were non-inferior to the widely used standard of care, latanoprost 0.005%, in lowering intraocular pressure. Patients treated with NCX 470 saw reductions of 7.9 to 10.0 mmHg from baseline, compared with 7.1 to 9.8 mmHg for latanoprost, the company says.

In a pre-specified secondary analysis, NCX 470 demonstrated statistically significant superiority over latanoprost at three of six timepoints and numerical improvements at five of six, though the trial did not meet its overall superiority benchmark, Nico says.

It says safety results were consistent with previous studies, with the most common side effect being conjunctival hyperemia (eye redness), reported in 22% of NCX 470 patients compared with 9.2% of those on latanoprost. No serious treatment-related ocular or systemic adverse events were observed, according to the company.

Nicox said it plans to meet with FDA in advance of its NDA filing and will present additional DENALI data at upcoming ophthalmology meetings.