Positive Phase II results for Nicox' NCX 470 in glaucoma trial

French ophthalmics-focussed biotech Nicox (Euronext Paris: COX) has presented results from the Dolomites Phase II clinical trial showing that NCX 470, a novel nitric oxide (NO)-donating prostaglandin analog (PGA), produced significantly greater intraocular pressure (IOP) lowering effects in glaucoma patients compared with the current standard of care, latanoprost.

In Dolomites, a dose-response Phase II clinical trial evaluating three concentrations of NCX 470 compared to latanoprost ophthalmic solution, 0.005% in 433 patients with open-angle glaucoma or ocular hypertension, NCX 470 0.065% achieved superiority compared to latanoprost 0.005% at all time points on day 28 with up to 1.4 mmHg superior IOP lowering.

All tested concentrations of NCX 470 were non-inferior to latanoprost and the dose response of NCX 470 showed improved IOP lowering with each incremental concentration. NCX 470 was safe and well-tolerated with no drug-related serious adverse events and no evidence of treatment-related systemic side effects.

The presentation of the results by Dr David Wirta, one of the clinical investigators in the trial, was made during the World Glaucoma Congress 2021. The Dolomites trial was completed in late 2019.