Nicox Announces Last Patients Complete Final Visit in NCX 470 Phase 3 Mont Blanc Glaucoma Trial

Nicox 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 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 analog 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 incontinuing 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 company news release. “NCX 470 has the potential to be a best-in-class glaucoma treatment, and we look forward to sharing the topline 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 our Chinese partner, Ocumension Therapeutics. Topline results is currently expected after 2024.