Nicox: Favorable Opinion from Chinese Regulator for NCX 470 Eye Drops
Ocumension Therapeutics, Nicox's exclusive partner in the Chinese market, received a favorable opinion from the Chinese health regulator (CDE) on Thursday regarding the NCX 470 eye drops, intended for the treatment of glaucoma. This regulatory approval paves the way for a marketing authorization application in China.
Regulatory Green Light in China for the Flagship Candidate
The Chinese Center for Drug Evaluation (CDE) has issued a favorable pre-submission opinion for NCX 470, an eye drop containing bimatoprost combined with a nitric oxide (NO) donor. This medication targets the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Based on this opinion, Ocumension considers that it has sufficient elements to file its marketing authorization application for NCX 470 with the National Institutes for Food and Drug Control (NIFDC) in China.
Two Major Regulatory Submissions in 2026
Kowa, Nicox's exclusive partner outside the Chinese market and the markets of South Korea and Southeast Asia, is expected to submit its application for authorization to the U.S. Food and Drug Administration (FDA) in the summer of 2026. The Chinese submission will follow shortly after the one in the United States. The Japanese regulatory program, meanwhile, began in the summer of 2025 with a phase 3 trial.
A Portfolio of Drugs in Development and Commercialized
Beyond NCX 470, Nicox markets Vyzulta, an eye drop against glaucoma authorized in the United States and in more than 15 other territories and licensed to Bausch + Lomb. The group also generates revenue through Zerviate, aimed at allergic conjunctivitis and marketed notably by Harrow in the United States. A preclinical research program on NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, is ongoing in partnership with Glaukos.
