Nicox Presented NCX 470 Phase 3 Mont Blanc Adaptive Design Data and Additional Subset Analysis Showing Superiority over Latanoprost at the World Glaucoma Congress

Press Release

Nicox Presented NCX 470 Phase 3 Mont Blanc Adaptive Design Data and Additional Subset Analysis Showing Superiority over Latanoprost at the World Glaucoma Congress

NCX 470 0.1% showed up to 1.73mmHg greater mean diurnal intraocular pressure (IOP) reduction from baseline than latanoprost in the adaptive dose selection period of the Phase 3 Mont Blanc trial

• NCX 470 demonstrated a statistically greater proportion of subjects with 10 mmHg or more IOP reduction compared to latanoprost in the Mont Blanc trial

July 3, 2023 – release at 7:30 am CET
Sophia Antipolis, France

Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that additional data on NCX 470 have been presented at the 10^th World Glaucoma Congress (WGC) being held from June 28 to July 1, 2023 in Rome, Italy.

“The large volume of data generated in the Mont Blanc Phase 3 trial on NCX 470 has provided us with the opportunity to look in detail at patient subgroups to further evaluate where NCX 470 has the greatest effect, some of which we are reporting here. Our first poster at the World Glaucoma Congress presents the adaptive dose selection data, justifying the choice of the 0.1% NCX 470 dose for the rest of the trial. We have also looked across the whole trial and report is that more patients achieve a reduction of IOP of 10mmHg or more when on NCX 470 than those on latanoprost. We look forward to reporting other data at conferences and in planned publications.” said Doug Hubatsch, Chief Scientific Officer of Nicox

Poster Title: NCX 470, a Nitric Oxide Donating Bimatoprost Compared with Latanoprost - Adaptive Design Period Results from the Phase 3 Mont Blanc Clinical Trial

A dose finding Phase 2 trial (Dolomites) tested NCX 470 at several concentrations and the results suggested that the highest studied dose might still be below the top of the dose response curve. To test this a concentration of 0.065% and 0.1% were included in an adaptive dose selection period of the Phase 3 Mont Blanc trial, which compared the safety and efficacy of NCX 470 ophthalmic solution vs. latanoprost ophthalmic solution in adult subjects with open-angle glaucoma or ocular hypertension. At the Week 2 timepoint, NCX 470 0.065% demonstrated 1.37 mmHg greater mean diurnal IOP reduction from baseline than latanoprost and NCX 0.1% demonstrated 1.73 mmHg greater mean diurnal IOP reduction from baseline than latanoprost.