Daily dosing of NCX 470 0.1% met the primary efficacy objective of demonstrating non-inferiority to latanoprost 0.005%, according to a report from international ophthalmic company, Nicox.
NCX 470, a novel nitric oxide (NO)-donating bimatoprost eye drop, is currently in a Phase 3 clinical program.
Nicox SA announced once daily dosing of NCX 470 0.1% met the primary objective of non-inferiority in lowering intraocular pressure (IOP) compared to the standard of care, latanoprost 0.005%, in the Mont Blanc Phase 3 clinical trial in patients with open-angle glaucoma or ocular hypertension.
Mont Blanc is a randomly assigned, multi-regional, double-masked, parallel group trial that evaluated the safety and efficacy of NCX 470 ophthalmic solution, 0.1% compared to latanoprost ophthalmic solution, 0.005% in 691 patients. Latanoprost is the most widely prescribed first-line therapy for open-angle glaucoma or ocular hypertension.
… the results demonstrate that NCX 470 has a robust intraocular pressure lowering effect, with good tolerability, and that it clearly met the primary objective of the Mont Blanc Phase 3 trial
Andreas Segerros, CEO of Nicox, noted in the news release that the results demonstrate that NCX 470 has a robust intraocular pressure lowering effect, with good tolerability, and that it clearly met the primary objective of the Mont Blanc Phase 3 trial.
“NCX 470 is the first non-combination product to demonstrate statistical non-inferiority, and numerically greater intraocular pressure reduction, compared to a prostaglandin analog in a pivotal trial,” he said in a statement.
“We are continuing to examine the Mont Blanc data including a number of additional ongoing pre-specified analyses which are important to fully define the profile of NCX 470, as well as further exploring NCX 470’s activity on retinal cell protection, beyond its intraocular pressure lowering properties.”
The similarly designed, ongoing, second Phase 3 trial, Denali, is being conducted at clinical sites in the United States and China, with top line results expected after 2024.
