Nicox Receives Positive Feedback from FDA for NCX 470 NDA

Nicox SA, a France-based ophthalmology company, announced that it has obtained positive feedback from a pre-NDA meeting with the U.S. FDA for its NCX 470 eye drop. The feedback indicates that the data package and NDA application format are generally acceptable for submission. The FDA requested additional pharmacokinetic data to be collected in Japan, which will not affect the submission timeline. The NDA is expected to be submitted in the summer of 2026.

NCX 470, a nitric oxide-donating bimatoprost eye drop, aims to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension. It has demonstrated the ability to reduce intraocular pressure by up to 10mmHg in clinical studies. Upon NDA submission, Nicox will receive a milestone payment from its partner Kowa, which is responsible for global commercial efforts, except in certain Asian markets licensed to Ocumension Therapeutics.