Nicox begins phase 3 trial of novel glaucoma drug
Nicox has enrolled the first 12 patients in a phase 3 clinical trial evaluating NCX 470, a novel second-generation nitric oxide-donating bimatoprost analog.
A company press release describes the Mont Blanc trial as “a multiregional, double-masked, 3-month, parallel group, adaptive design trial evaluating the efficacy and safety of NCX 470 ophthalmic solution 0.065% and 0.1% compared to latanoprost ophthalmic solution 0.005% in patients with open-angle glaucoma or ocular hypertension.”
In the trial’s adaptive portion, one dose will be selected for a head-to-head 3-month safety and efficacy study against latanoprost. The trial is designed to randomize more than 600 patients at clinical sites in the United States as well as some sites in China.
NCX 470 demonstrated statistical non-inferiority and superiority to latanoprost in a phase 2 trial.
“We have assembled a group of top glaucoma clinical investigators who are enthusiastic to participate in the Mont Blanc trial, based on the promising NCX 470 results from our phase 2 Dolomites trial. The adaptive design of the Mont Blanc trial will allow us to select the optimal NCX 470 dose for the remainder of the trial and, shortly thereafter, to start our second phase 3 trial, Denali,” Tomas Navratil, PhD, executive vice president and head of research and development for the Nicox Group and general manager of Nicox Ophthalmics, said in the release.
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