Nicox announces recruitment of last patient in US in Denali Phase 3 trial of NCX 470

Key Takeaways

• NCX 470 is a novel, once-a-day eye drop that includes two complementary activities in a single molecule to combat high intraocular pressure (IOP).
• Nicox announced the recruitment of the last patient in the U.S. for its Phase 3 clinical trial of NCX 470 for the treatment of glaucoma and ocular hypertension. 

Abnormally high pressure in the eye (elevated intraocular pressure, IOP) is regarded as one of the most important risk factors for developing glaucoma. NCX 470 is a novel eye drop that includes two complementary activities in a single molecule to combat high IOP. 

In a news release, Nicox SA announced the recruitment and randomization of the last patient in the U.S. in its Denali Phase 3 trial of NCX 470, which is evaluating the safety and efficacy of once-daily dosed NCX 470 ophthalmic solution 0.1% compared to latanoprost ophthalmic solution 0.005% in patients with open-angle glaucoma or ocular hypertension. The trial is a multi-country (U.S. and China) clinical trial that, together with the Mont Blanc trial, was designed to fulfill the regulatory requirements to support New Drug Application (NDA) submissions of NCX 470 in the U.S. and China. Results are expected in the second half of 2025, and the U.S. NDA for NCX 470 is expected to be submitted in in the first half of 2026.

The first Phase 3 trial, Mont Blanc, met the efficacy requirements for approval in the U.S. NCX 470 was well tolerated and discontinuation rates were low.

For more information on the Denali trial, visit https://clinicaltrials.gov/study/NCT04630808 or contact Nicox Ophthalmics by calling 984-710-5354 or by emailing NCX470@nicox.com. 

Edited by Miriam Kaplan, PhD

Source: David Hutton, Ophthalmology Times, July 25, 2024; see source article