Nicox Reports Achieving Primary Objective in Mont Blanc,

• Mont Blanc, the first of two Phase 3 trials for NCX 470, met the efficacy requirements for approval in the United States
• Daily dosing of NCX 470 0.1% met the primary efficacy objective of demonstrating non-inferiority to latanoprost 0.005%, with NCX 470 showing 8.0 to 9.7 mmHg intraocular pressure lowering from baseline
• NCX 470 0.1% was statistically superior to latanoprost 0.005% in intraocular pressure reduction from baseline at 4 of the 6 timepoints, and numerically greater at all 6 timepoints However the secondary efficacy objective, statistical superiority to latanoprost, was not achieved
• NCX 470 0.1% was well tolerated

October 31, 2022 – release at 7:30 am CET
Sophia Antipolis, France

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that 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 691-patient Mont Blanc Phase 3 clinical trial in patients with open-angle glaucoma or ocular hypertension. The IOP-lowering effect from baseline for NCX 470 was 8.0 to 9.7 mmHg vs. 7.1 to 9.4 mmHg for latanoprost (reduction in time-matched IOP at 8 AM and 4 PM across the week 2, week 6 and month 3 visits). In a pre-specified secondary efficacy analysis of time-matched change from baseline IOP, statistical superiority was not achieved, however the IOP reductions for NCX 470 were numerically greater than those for latanoprost at all 6 timepoints, and statistically significant (p<0.049) at 4 of the 6 timepoints.   NCX 470, a novel nitric oxide (NO)-donating bimatoprost eye drop, is currently in a Phase 3 clinical program.  

“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.   NCX 470 is the first non-combination product to demonstrate statistical…