Nicox SA 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 teek 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 time points, and statistically significant (pThese 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 non-inferiority, and numerically greater intraocular pressure reduction, compared to a prostaglandin analog in a pivotal trial. We are continuing to examine the Mont Blanc data including a number of additional ongoing pre-specified analyses which are important to fully define the profile of NCX 470, as well as further exploring NCX 470's activity on retinal cell protection, beyond its intraocular pressure lowering properties. NCX 470 Glaucoma Mont Blanc Phase 3Topline Results Summary: IOP-lowering effect from baseline was 8.0 to 9.7 mmHg for NCX 470 vs.

7.1 to 9.4 mmHg for latanoprost. Non-inferiority was met vs. latanoprost in the primary efficacy analysis.

The upper limit of the 95.1% confidence limit on the difference in the treatment effect between NCX 470 and latanoprost in change from baseline in time-matched IOP to the follow-up visits (week 2, week 6, and month 3) was =1.5 mmHg and =1.0 mmHg at all 6 time points.