Nicox’s NCX 470 Demonstrates Sustained Efficacy through 12 Months in Phase 3 Trial

Nicox announced it has completed additional pre-planned analyses from its NCX 470 Denali phase 3 clinical trial. The results confirm an efficacy profile consistent with the Mont Blanc phase 3 trial subgroup analyses and demonstrate sustained IOP reduction through 12 months of treatment with no new safety signals.

According to Nicox, the Denali trial confirmed that NCX 470 ophthalmic solution, 0.1%, maintained significant and durable IOP reduction in patients with open-angle glaucoma or ocular hypertension. During the long-term safety extension (6–12 months), patients continued to show robust IOP control, reinforcing the therapy’s potential as a new standard in glaucoma management.

The Denali study was a randomized, multi-regional, double-masked, parallel-group phase 3 trial conducted at 90 sites in the US and China, enrolling 696 patients. The trial compared NCX 470, a nitric oxide-donating bimatoprost analog, with latanoprost ophthalmic solution, 0.005%, the most widely prescribed first-line therapy for glaucoma.

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

• Extension period: Long-term safety evaluation from 6–12 months

• Collaboration: Conducted and equally financed with Chinese partner Ocumension Therapeutics

Results showed that NCX 470 achieved strong IOP reduction consistent with prior findings, with a favorable safety profile extending over 12 months.

Nicox is advancing regulatory preparations in key global markets, with several milestones ahead:

• United States NDA submission: expected in the first half of 2026

• China NDA submission: expected shortly after US filing

• Japan Phase 3 program: initiated in summer 2025, managed and financed by partner Kowa