Nicox annonce une réunion pré-NDA positive avec la FDA américaine pour NCX 470

Core Insights - Nicox SA received positive feedback from the FDA following a pre-NDA meeting regarding NCX 470, indicating that the current data package and proposed NDA format are generally acceptable for submission [1][2] - The NDA submission is scheduled for summer 2026, with additional pharmacokinetic data required from an ongoing study in Japan, which will not affect the timeline [1][4] Company Overview - Nicox SA is an international ophthalmology company focused on developing innovative solutions for vision maintenance and eye health [4] - The primary advanced development program is NCX 470, an innovative nitric oxide donor eye drop aimed at reducing intraocular pressure in patients with open-angle glaucoma or ocular hypertension [1][4] Licensing and Financial Aspects - NCX 470 is globally licensed to Kowa, except for China, South Korea, and Southeast Asia, where the license is granted to Ocumension Therapeutics [3][6] - Nicox will receive regulatory milestone payments and sales-related milestone payments, as well as royalties on global sales, while Kowa and Ocumension will cover all regulatory and marketing costs [3][6] Clinical Development - The NDA submission for NCX 470 in China is expected shortly after the submission in the United States [5] - A Phase 3 clinical program for NCX 470 in Japan was initiated in summer 2025 [5]