According to Nicox SA, the patients made their final 3-month visit last week. Top line results of the trial are expected in November.
Nicox SA announced that the last patients completed their final (3-month) visit in the Mont Blanc Phase 3 clinical trial of NCX 470 0.1% for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
A total of 691 patients were enrolled in the trial. 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 Phase 3 clinical trial, and I would particularly like to thank our clinical sites and the Nicox development team for their incredible efforts in continuing to drive this trial to completion in the face of the COVID-19 pandemic situation.” Doug Hubatsch, EVP, Chief Scientific Officer of Nicox, said in a news release. “NCX 470 has the potential to be a best-in-class glaucoma treatment, and we look forward to sharing the top line results in early November.”
Mont Blanc is 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.
The second Phase 3 trial on NCX 470, Denali, is being jointly conducted and equally financed with Nicox SA’s Chinese partner, Ocumension Therapeutics. Top line results are currently expected after 2024.