NCX 470 noninferior to latanoprost in phase 3 glaucoma trial
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Once-daily dosing of NCX 470 demonstrated noninferiority compared with latanoprost in lowering IOP in patients with open-angle glaucoma or ocular hypertension in the phase 3 Mont Blanc clinical trial.
The trial, which enrolled 691 participants at 56 sites in the U.S. and one site in China, investigated the efficacy and safety of NCX 470 ophthalmic solution 0.1% for IOP reduction from baseline at six timepoints: 8 a.m. and 4 p.m. at week 2, week 6 and month 3.
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IOP decreased 8 mm Hg from baseline to 9.7 mm Hg in those who received NCX 470 compared with 7.1 mm Hg to 9.4 mm Hg for latanoprost ophthalmic solution 0.005% across the timepoints, according to a press release from Nicox. Additionally, a secondary efficacy analysis found that NCX 470 achieved statistically significant greater reductions in IOP at four of the six timepoints (P < .049) and numerically greater reductions at all six timepoints compared with latanoprost, but NCX 470 did not achieve the secondary efficacy endpoint of statistical superiority.
The nitric oxide-donating bimatoprost eye drop was well tolerated with no ocular serious adverse events and no treatment-related non-ocular serious adverse events. The most common adverse event was ocular hyperemia in 11.9% of subjects treated with NCX 470 compared with 3.3% of subjects treated with latanoprost.
“These 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, said in the release. “NCX 470 is the first non-combination product to demonstrate statistical noninferiority, and numerically greater intraocular pressure reduction, compared to a prostaglandin analogue in a pivotal trial.”
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