NCX 470 Shows Sustained Efficacy in Denali Phase 3 Trial

Nicox SA has reported positive outcomes from additional pre-planned analyses of the Denali Phase 3 trial evaluating NCX 470 ophthalmic solution, 0.1%, in patients with open-angle glaucoma or ocular hypertension. The results confirm sustained intraocular pressure (IOP) reduction through 12 months, aligning with earlier findings from the Mont Blanc trial, and show no new safety concerns, supporting NCX 470's potential as a future treatment option.

Confirmed Long-Term Efficacy and Safety Profile

According to Nicox, patients treated with NCX 470 maintained durable and clinically meaningful IOP reduction throughout the 6–12-month safety extension period. These findings reinforce the candidate's potential to set a new standard in the management of glaucoma and ocular hypertension.

The Denali trial is a randomized, multi-regional, double-masked, parallel-group Phase 3 study conducted across 90 clinical sites in the U.S. and China, enrolling 696 patients. The trial compared NCX 470, a nitric oxide–donating bimatoprost analog, with latanoprost 0.005%, the most widely prescribed first-line glaucoma therapy.

Trial Design and Key Outcomes

• Primary efficacy endpoint: Reduction from baseline in mean time-matched IOP measured at six timepoints (8 AM and 4 PM at week 2, week 6, and month 3)

• Extension period: Long-term safety and efficacy evaluation from 6 to 12 months

• Collaboration: The trial was co-conducted and equally financed with Chinese partner Ocumension Therapeutics

NCX 470 demonstrated IOP-lowering efficacy consistent with prior trials and maintained a favorable safety profile, with no unexpected adverse events reported over the 12-month period.