Nicox is preparing an NDA submission for NCX 470 following a positive FDA opinion

Ninox, an ophthalmology company, announced that it has received a positive opinion from the Food and Drug Administration (FDA) for its product NCX 470 at a pre-NDA meeting. The submission of the National Development Application (NDA) in the United States is planned for summer 2026. The product, an eye drop solution designed to reduce intraocular pressure, demonstrated a significant reduction in intraocular pressure in patients during Phase 3 clinical trials. Ninox will transfer ownership of the dossier to Kowa for the NDA submission. In addition, following requests from the FDA, further pharmacokinetic data will be collected without affecting the planned timeline.