- The last patients ended their last (3 month) visit on September 16th
- 691 patients was enrolled in the Mont-Blanc study
- Topline results of the Mont Blanc process due In early November 2022
September 19, 2022 – Release at 7:30am BST
Sophia Antipolis, France
Nicox S.A FR COX))), an international ophthalmology company, announced today that the final patients completed their final (3-month) visit in Mont Blanc’s Phase 3 clinical trial of NCX 470 0.1% for the reduction of intraocular pressure ( IOP) in patients with open-angle glaucoma or ocular hypertension. A total of 691 patients were included in the study. NCX 470, Nicox’s lead clinical product candidate, is a novel, potentially best-in-class, nitric oxide (NO) donating prostaglandin analogue eye drop.
“We are pleased to have reached this milestone in the Mont-Blanc stage 3 clinical study, and I would like to especially thank our clinical sites and the Nicox development team for theirs unbelievable efforts in furthereng to drivee this attempt until completion given the COVID-19 pandemic situation.” said Doug Hubatsch, EVP, Scientific Director Officer of Nicox. “NCX 470 has the potential be top-notch glaucoma treatment, and we look forward to Divide the top line rightResults in early November.“
Mont Blanc is a multi-regional, double-blind, 3-month, parallel-group study to evaluate the efficacy and safety of NCX 470 ophthalmic solution 0.1% compared to latanoprost ophthalmic solution 0.005%. Latanoprost is the most commonly prescribed first-line treatment for open-angle glaucoma or ocular hypertension. The primary efficacy assessment at Mont Blanc is based on timed IOP at 8:00 a.m. and 4:00 p.m. at week 2, week 6 and month 3.
The second phase 3 study of NCX 470, Denali, is being conducted jointly and equally funded with our Chinese partner Ocumension Therapeutics. Topline results are currently being ranked according to…
