Nicox has received approval from the U.S. Patent and Trademark Office of a formulation patent for NCX 470, extending the U.S. patent coverage to 2039.
NCX 470, a novel second generation nitric oxide (NO)-donating bimatoprost analog for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension, is Nicox’s lead clinical development program. NCX 470 ophthalmic solution 0.065% demonstrated noninferiority and statistical superiority to latanoprost ophthalmic solution 0.005%, the U.S. market leader in prostaglandin analog prescriptions, in the Dolomites trial, a U.S., multicenter, phase 2 safety and efficacy clinical trial.
An end-of-phase 2 meeting with the FDA is scheduled in Q1 2020. The initiation of the first of the two U.S. phase 3 clinical trials (Mont Blanc) is expected by the end of Q2 2020.
NCX 470 is covered by a composition of matter patent until 2029, which is potentially eligible for up to a 5-year patent term extension based on the period of regulatory review.