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Nicox - NCX-470 non-inferior to latanoprost in Mont Blanc

Nicox’s Mont Blanc Phase III study of NCX-470 0.1% met the primary efficacy endpoint of demonstrating non-inferiority to latanoprost 0.005% for the reduction in intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Given the favourable safety profile also shown, these results bode well for the product’s likelihood of obtaining FDA approval, provided the second Phase III study, Denali, demonstrates similar efficacy parameters (results expected by Nicox after 2024). Mont Blanc did not meet the secondary endpoint of demonstrating statistical superiority to latanoprost, although NCX-470 showed statistically superior IOP reduction (p<0.049) at four of the six timepoints and numerically greater IOP reduction at all six timepoints. Altogether, the extent of NCX-470’s difference with latanoprost does not appear to be as substantial as what was shown in the earlier Dolomites Phase II study, which may restrain expectations surrounding the product’s differentiated positioning compared to the leading prostaglandin F2α analogue (PGA) drugs.