Nicox announced that its investigational nitric oxide-donating prostaglandin analog, NCX 470, met the primary endpoint in the phase 3 Denali trial, demonstrating noninferiority to latanoprost in lowering intraocular pressure (IOP). The company said the results, which confirm findings from the earlier phase 3 Mont Blanc study, will support regulatory submissions in both the United States and China.

The multicenter Denali trial enrolled 696 patients with open-angle glaucoma or ocular hypertension. Once-daily NCX 470 achieved mean IOP reductions of 7.9 to 10.0 mmHg from baseline, compared with 7.1 to 9.8 mmHg for latanoprost. Secondary analyses showed numerically greater reductions with NCX 470 at most timepoints, reaching statistical significance at 3 of them, though superiority was not established. Safety was consistent with prior trials, with conjunctival hyperemia the most common adverse event.

Nicox said in a press release that it will meet with the US Food and Drug Administration (FDA) soon to discuss a potential New Drug Application. Through its partnerships with Kowa and Ocumension, the company anticipates potential US royalties beginning in 2027 and commercialization in Asian markets thereafter.