Nicox SA announced that it has closed screening for additional patients in its Phase 3 Mont Blanc clinical trial of NCX 470 0.1% in patients with open-angle glaucoma or ocular hypertension. Therefore, the Company now expects to advance the announcement of the Mont Blanc topline results to November 2022, as opposed to First Quarter 2023. NCX 470 0.065% has already demonstrated a statistically significant greater reduction of intraocular pressure compared to latanoprost 0.005% in a Phase 2 trial and is being evaluated in Phase 3 at a higher concentration than was tested in Phase 2. In the earlier Dolomites Phase 2 clinical trial, NCX 470 0.065% demonstrated statistical superior lowering of intraocular pressure of up to 1.4 mmHg compared to latanoprost 0.005% at Day 28.

The results of the Dolomites trial were recently published in the Journal of Glaucoma. Mont Blanc is a Phase 3 clinical trial in patients with elevated intraocular pressure due to open-angle glaucoma or ocular hypertension. The Mont Blanc Phase 3 trial had an initial adaptive design period during which NCX 470 0.065% was evaluated together with the higher concentration of NCX 470 0.1%.

Following the adaptive design period, the NCX 470 0.1% concentration was chosen to continue in the Mont Blanc Phase 3 trial, and was used to initiate the second Phase 3 clinical trial, Denali. Mont Blanc continued after the adaptive design period as a multi-regional, double-masked, 3-month, parallel group trial evaluating the efficacy and safety of NCX 470 ophthalmic solution 0.1% compared to latanoprost ophthalmic solution, 0.005%. Latanoprost is the most widely prescribed first-line therapy for open-angle glaucoma or ocular hypertension.

The primary efficacy evaluation in Mont Blanc is based on time-matched IOP at 8 AM and 4 PM at Week 2, Week 6 and Month 3. Nicox retains 100% of the rights to NCX 470, notably in U.S., Europe and Japan, other than those licensed to its partner Ocumension Therapeutics in China and elsewhere in the Far East. Nicox intends to continue developing NCX 470 itself in the U.S., and to partner in other key territories, particularly in Japan, as a key market opportunity. The Denali topline results are expected after 2023 and the Company will announce a new date for availability of the results when the company have a more firm estimate of the overall timelines of the trial.