Nicox Completes Phase 3 Denali Trial of NCX 470 in Open-Angle Glaucoma and Ocular Hypertension
Nicox has announced the completion of patient participation in its Denali Phase 3 trial, which assesses the efficacy and safety of NCX 470 in patients with open-angle glaucoma or ocular hypertension. According to the company, all 696 patients enrolled in the trial have now completed their treatment and follow-up visits.
Company Anticipates Topline Results to Strengthen NCX 470 Profile
In a company press release, Doug Hubatsch, Chief Scientific Officer of Nicox, commented on the milestone. He stated, “We look forward to announcing the topline results in the near future, which we expect will further consolidate the profile of NCX 470 and confirm its potential in the glaucoma market. We remain fully focused on completing the clinical development program and preparing for regulatory submissions.”
About NCX 470: Dual Mechanism for Lowering IOP
NCX 470 is a novel nitric oxide (NO)-donating bimatoprost eye drop that combines the IOP-lowering effects of NO and prostaglandin analogs (PGAs). It is designed to release bimatoprost and NO into the eye, lowering intraocular pressure (IOP) through two different pathways in patients with open-angle glaucoma or ocular hypertension. NCX 470 integrates Nicox’s proprietary NO-donating research platform with bimatoprost in a single molecule.
Clinical Development Pathway and Regulatory Timeline
The Denali trial, along with the previously completed Mont Blanc trial, is intended to meet the clinical regulatory requirements to support New Drug Application (NDA) submissions for NCX 470 in the United States and China. Nicox anticipates submitting an NDA to the US FDA in the first half of 2026.
The topline results from the Denali trial are expected between mid-August and mid-September 2025. Additionally, Nicox plans to begin Phase 3 clinical efficacy and long-term safety trials in Japan in the second half of 2025.
