Nicox Completes Regulatory Data for NCX 470 Prior to US Submission
The ophthalmic laboratory Nicox has announced the completion of data generation and analysis necessary for the submission of marketing authorization applications for its NCX 470 treatment in the United States and China, according to a statement released on Monday.
Comprehensive Data Compilation
The company reports that it has completed all data from clinical trials and long-term stability studies on batches of active ingredient and finished product of NCX 470. These elements, in line with the guidelines of the International Council for Harmonisation, are a standard component of a marketing authorization application. They particularly support the manufacturing processes, the shelf life of the active ingredient and finished product, and the study of the drug's metabolism. The company specifies that the preparation of the regulatory dossier is fully funded by its partner Kowa.
Pre-NDA Meeting Preparation
Nicox is preparing for a pre-NDA meeting with the U.S. Food and Drug Administration, a routine step in which a pharmaceutical company meets with the agency before submitting its application. The submission of the marketing authorization application in the United States remains scheduled for the first half of 2026, in accordance with the planned timeline, according to the group. Doug Hubatsch, Chief Scientific Officer of Nicox, emphasizes in the statement that this step represents an important milestone towards the long-term value creation of the product.
International Expansion and Clinical Programs
In addition to the United States, the company indicates that a submission for marketing authorization in China is also well on track for 2026, shortly after the American submission. Additionally, a phase 3 clinical program for NCX 470 in Japan was initiated in the summer of 2025, managed and funded by Kowa. NCX 470 is a nitric oxide-donating bimatoprost eye drop intended for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. This treatment is licensed to Ocumension Therapeutics for the Chinese, Korean, and Southeast Asian markets, and to Kowa for the rest of the world.
