Nicox has announced the completion of data collection for the Whistler Phase 3b clinical trial investigating NCX 470’s efficacy in lowering intraocular pressure (IOP). The last patient has completed their final visit, marking a significant milestone in the development of this novel treatment for glaucoma and ocular hypertension.
NCX 470 (bimatoprost grenod) is a nitric oxide (NO)-donating bimatoprost eye drop with a dual mechanism of action. It combines the IOP-lowering effects of nitric oxide with a prostaglandin analog, aiming to enhance aqueous humor outflow through the trabecular meshwork while reducing episcleral venous pressure.
The Whistler Phase 3b study was a double-masked, placebo-controlled trial designed to evaluate NCX 470’s impact on aqueous humor dynamics. A total of 18 volunteers with ocular hypertension participated in the study, each undergoing an 8-day treatment period.
Nicox anticipates releasing the Whistler trial results in May 2025. In parallel, the company’s Denali Phase 3 trial is progressing, with the final U.S. patient visit now completed. Patient recruitment and treatment continue in China, where results are expected later this year.
NCX 470 is Nicox’s lead clinical candidate and is in Phase 3 clinical trials to support regulatory approval for glaucoma treatment in the U.S. and China. The Mont Blanc Phase 3 trial, the first of the two pivotal studies, has been completed, with published results available on Nicox’s website. The ongoing Denali trial is structured to meet the necessary safety and efficacy requirements for New Drug Application (NDA) submissions in both markets.
Additionally, NCX 470 is exclusively licensed to Ocumension Therapeutics for China and to Kowa for Japan, extending its global development strategy.
With the completion of the Whistler Phase 3b trial’s data collection, Nicox moves one step closer to advancing NCX 470 for regulatory approval. The forthcoming results will provide critical insights into its mechanism of action and efficacy, further shaping the landscape of glaucoma treatment.