Nicox Announces Positive Feedback from pre-NDA Meeting with U.S. FDA for NCX 470

Core Viewpoint - Nicox SA has received positive feedback from the U.S. FDA regarding the pre-NDA meeting for NCX 470, indicating that the data package and proposed NDA content are generally acceptable for submission, with the NDA submission expected in summer 2026 [1][2]. Group 1: FDA Meeting and NDA Submission - The FDA meeting was productive and collaborative, supporting the finalization of the registration dossier, which includes positive results from two Phase 3 studies [2]. - The FDA has requested additional pharmacokinetic data from an ongoing study in Japan, which will not affect the NDA submission timeline [1]. - The NDA submission is on track for summer 2026, with Nicox set to receive a milestone payment from Kowa upon submission [5][6]. Group 2: Product Information - NCX 470 is a novel nitric oxide-donating bimatoprost eye drop designed to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension [1][7]. - The product is licensed globally to Kowa, except in China, South Korea, and Southeast Asia, where it is licensed to Ocumension Therapeutics [3]. Group 3: Future Milestones - The NDA submission in the U.S. is expected in summer 2026, with a subsequent submission in China anticipated shortly after [6]. - The Phase 3 clinical program for NCX 470 in Japan was initiated in summer 2025 [6].