Nicox’s second generation nitric oxide-donating bimatoprost analog NCX 470 met the primary endpoint of non-inferiority compared with latanoprost 0.005% in a dose-ranging study, according to a company press release.
The phase 2 multicenter Dolomites trial, which encompassed 433 patients with open-angle glaucoma or ocular hypertension, found NCX 470 0.065% reduced IOP 7.6 mm Hg to 9.8 mm Hg from baseline at day 28. In the latanoprost group, time-matched IOP was reduced 6.3 mm Hg to 8.8 mm Hg.
“If these results are confirmed in phase 3 clinical trials, NCX 470 could potentially become the first non-combination product with statistical superiority to a prostaglandin analog,” Michele Garufi, Nicox chairman and CEO, said. “Moreover, NCX 470 has demonstrated what we believe to be the highest IOP reduction from baseline in a glaucoma clinical trial.”
The company plans to meet with the FDA in early 2020 to discuss phase 3 trials.