French company Nicox SA announced today the results of its Whistler phase 3b exploratory trial evaluating NCX 470, a nitric oxide–donating prostaglandin analog, in healthy volunteers and patients with ocular hypertension. The study assessed changes in aqueous humor dynamics to better understand the drug’s dual mechanism of intraocular pressure (IOP) reduction.
Several parameters associated with nitric oxide and prostaglandin analog activity showed statistically significant changes or trended in favor of NCX 470, the company reported. These included aqueous humor flow rate (P=.072), outflow facility (P=.001 at 3 pm), and diurnal outflow (P=.004). IOP lowering and uveoscleral outflow were statistically significant at all time points. Episcleral venous pressure did not show a notable difference vs placebo.
The safety profile observed was consistent with that reported in Mont Blanc, the first phase 3 trial for NCX 470. The Whistler trial was not designed to support regulatory submissions, but Nicox said its timeline for New Drug Applications remains on track. NCX 470 is currently being evaluated in the phase 3 Denali trial, and full safety and efficacy results are expected in the third quarter of 2025. GP