Nicox has announced receiving positive written feedback from the U.S. Food and Drug Administration (FDA) following its pre-NDA meeting on NCX 470, an innovative eye drop aimed at reducing intraocular pressure. The submission of the marketing authorization application in the United States is still scheduled for summer 2026.
The FDA has confirmed that the current data package as well as the proposed content and format of the marketing authorization application (NDA) are generally acceptable for submission. The agency has requested additional pharmacokinetic data, which will be generated from a small number of patients in an ongoing study in Japan. According to Nicox, these additional data will not impact the planned timeline. NCX 470 (bimatoprost grenod) is a nitric oxide-donating bimatoprost eye drop intended for patients with open-angle glaucoma or ocular hypertension.
Transfer of Registration File to Kowa
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Nicox will transfer the registration dossier to Kowa so that it can proceed with the submission to the FDA as planned in summer 2026. Nicox will receive a milestone payment from Kowa at the time of the NDA submission. The product is globally licensed to Kowa, except for the Chinese, Korean, and Southeast Asian markets, where the license is granted to Ocumension Therapeutics. An NDA submission in China is planned shortly after the American submission, while a Phase 3 clinical program in Japan was initiated in the summer of 2025.
Nicox a significativement renforcé sa position financière en 2025.
Risks mentioned
Baisse potentielle de la demande pour les nouveaux produits.
Risque de retard dans les soumissions réglementaires.
Opportunities identified
Soumission prévue de la NDA de NCX 470 aux États-Unis en été 2026.
Initiation du programme clinique de phase 3 pour NCX 470 au Japon.
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