Nicox’s NCX 470 Mont Blanc Phase 3 Glaucoma Trial Reaches 50% Enrollment Milestone - Seite 2

Denali, the second multi-regional Phase 3 clinical trial of NCX 470 for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension, was initiated in the U.S. in November 2020, and approval was recently obtained to start recruitment in China.  Denali is a 3-month trial evaluating the safety and efficacy of NCX 470 ophthalmic solution, 0.1% versus latanoprost ophthalmic solution, 0.005% that will also include a long-term safety extension.  The trial is financed jointly and in equal parts by Nicox and Ocumension and includes clinical sites in both the U.S. and China, with the majority of the patients to be recruited in the U.S.  Top-line efficacy results are currently expected in Q4 2022.

The Denali trial, together with the ongoing Mont Blanc trial, are designed to fulfill the regulatory requirements for Phase 3 safety and efficacy trials to support New Drug Application (NDA) submissions in the U.S. and China. 

We continue to closely watch the spread and impact of the COVID-19 pandemic and we will provide an update of any delays. About NCX 470 NCX 470 is a novel, potential best-in-class, nitric oxide (NO)-donating prostaglandin analog in development to reduce intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.  Glaucoma is a group of ocular diseases in which the optic nerve is injured, leading to peripheral and, ultimately, central visual field loss and it can eventually lead to blindness if not treated.  It is frequently linked to abnormally high IOP (~90% of patients) due to blockage or malfunction of the eye’s aqueous humor drainage system in the front of the eye.  In 2019, worldwide sales of treatments targeting glaucoma were over $6.0 billion out of a $21.9 billion worldwide market for ophthalmic drugs. 

NCX 470 is designed to release both bimatoprost and NO following instillation into the eye.  Bimatoprost, marketed under the brand name LUMIGAN by Allergan, Inc., is one of the leading products in the class of prostaglandin analogs, the most widely used class of drugs for IOP-lowering in patients with open-angle glaucoma or ocular hypertension. About Nicox Nicox S.A. is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health.  Nicox’s lead program in clinical development is NCX 470, a novel nitric oxide-donating prostaglandin analog, for lowering intraocular pressure in patients with glaucoma.  The company is also developing NCX 4251, a proprietary formulation of fluticasone, for acute exacerbations of blepharitis.  Nicox generates revenue from VYZULTA in glaucoma, licensed exclusively worldwide to Bausch + Lomb, and ZERVIATE in allergic conjunctivitis, licensed in multiple geographies, including to Eyevance Pharmaceuticals, LLC, in the U.S. and Ocumension Therapeutics in the Chinese and in the majority of South East Asian markets.