Nicox Announces Results of the Exploratory Whistler Phase 3b Glaucoma Trial

Core Viewpoint - Nicox SA announced positive results from the Whistler Phase 3b exploratory trial for NCX 470, indicating its potential as a differentiated treatment for lowering intraocular pressure (IOP) in patients with glaucoma and ocular hypertension [1][2][3]. Group 1: Trial Results - The Whistler trial demonstrated that NCX 470 showed favorable outcomes in several aqueous humor dynamics parameters, attributed to its dual mechanism of action involving nitric oxide and prostaglandin analogs [2][3]. - Statistically significant results were observed for IOP lowering and uveoscleral outflow at all measured time points, with outflow facility showing significance at 3 pm (p=0.001) and diurnal outflow at p=0.004 [3][5]. - The trial involved 18 healthy volunteers with mean baseline IOPs of 16.6 mmHg for NCX 470 and 16.9 mmHg for placebo, indicating a normotensive population [4][5]. Group 2: Future Developments - The ongoing Phase 3 trial, Denali, is expected to provide further safety and efficacy results in Q3 2025, which will support New Drug Application submissions in the U.S. and China [2][7]. - The safety profile of NCX 470 in the Whistler trial was consistent with the earlier Mont Blanc trial, which has already demonstrated its efficacy [3][5]. Group 3: Company Overview - Nicox SA is focused on developing innovative ophthalmic solutions, with NCX 470 being its lead product candidate for lowering IOP in open-angle glaucoma and ocular hypertension [8]. - The company also has a preclinical program for NCX 1728 and generates revenue from its commercial product, VYZULTA®, and ZERVIATE® [8].