Ophthalmology company Nicox SA (Euronext Growth Paris:ALCOX) announced on Tuesday that it has completed the generation and analysis of all clinical trial and long-term stability data required to support New Drug Application (NDA) submissions for NCX 470 in the United States and China.

The data package, compliant with International Council for Harmonisation guidelines, covers both drug substance and finished drug product and supports manufacturing, shelf-life and drug metabolism requirements.

The company is preparing for a pre-NDA meeting with the US Food and Drug Administration (FDA), with the US NDA submission on track for the first half of 2026 and the China submission expected shortly thereafter. Preparation of the NDA is being funded by licensing partner Kowa.

Nicox confirmed that the Phase 3 clinical program for NCX 470 in Japan was initiated in summer 2025 and is managed and financed by Kowa.