Nicox Announces Last Patient Completes Final Visit in NCX 470 Phase 3b Whistler Glaucoma Trial

Press Release

Nicox Announces Last Patient Completes Final Visit in NCX 470 Phase 3b Whistler Glaucoma Trial

Results expected in May 2025 Last patient in the U.S. in the ongoing NCX 470 Denali Phase 3 trial has also completed their last visit and results remain on track for Q3 2025 March 19, 2025 – release at 7:30 am CET Sophia Antipolis, France Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that the last patient completed their final visit in the Whistler     Phase 3b clinical trial investigating the dual mechanism of action (nitric oxide and prostaglandin analog) of NCX 470 in intraocular pressure (IOP) lowering.  The Whistler Phase 3b trial enrolled 18 healthy volunteers with ocular hypertension in a double-masked, placebo-controlled study investigating the action of NCX 470 on aqueous humor parameters including trabecular meshwork outflow and episcleral venous pressure. Each subject participated in the trial for approximately 8 days. About NCX 470 NCX 470, Nicox’s lead clinical product candidate, is a novel NO-donating bimatoprost eye drop, currently in Phase 3 clinical development for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension. Results of Mont Blanc, the first of the two Phase 3 clinical trials, have been extensively published and are available on our website. The second Phase 3 clinical trial, Denali, is currently ongoing. The last American patient in Denali has completed their final visit, with Chinese patients completing theirs, and the results are expected in Q3 2025. Mont Blanc and Denali have been designed to fulfill the regulatory requirements for safety and efficacy Phase 3 trials to support NDA submissions in both the U.S. and in China, where NCX 470 is exclusively licensed to Ocumension Therapeutics. NCX 470 is also licensed exclusively to Kowa for Japan.