Nicox: NCX 470 has achieved the primary objective of the Mont Blanc study (glaucoma) – 31/10/2022 at 10:07


(AOF) – Nicox SA, an international specialty ophthalmology company, today announces that NCX 470 0.1% administered once daily has achieved the primary endpoint of non-inferiority in the reduction of intraocular pressure (IOP) compared reference treatment, latanoprost 0.005%, in the phase 3 Mont Blanc study conducted in 691 patients with open-angle glaucoma or ocular hypertension.

The IOP lowering effect from baseline was 8.0 to 9.7 mmHg for NCX 470 versus 7.1 to 9.4 mmHg for latanoprost (IOP reduction at time points at 8 a.m. and 4 p.m. for visits in the second week, 6th week and 3rd month). Latanoprost is the most widely prescribed first-line treatment for open-angle glaucoma or ocular hypertension.

In a pre-specified secondary efficacy analysis of change from baseline at IOP assessment times, statistical superiority was not achieved, however IOP reductions were numerically greater than those of latanoprost at all 6 assessment points and statistically significant (p<0.049) at 4 of the 6 assessment points.

NCX 470, a novel nitric oxide (NO)-donating bimatoprost eye drop, is currently in Phase 3 clinical development.

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