• Exclusive licensee for China, Ocumension, received positive pre-submissionregulatory feedback from the Chinese Center for Drug Evaluation (CDE) forNCX 470
• Based on this feedback, Ocumension intends to proceed with the New DrugApplication (NDA) submission in China
• Submission should follow shortly after NCX 470 NDA to the U.S. Food andDrug Administration (FDA), expected summer 2026
June 18, 2026 – release at 7:30 am CETSophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmologycompany, today announced that its exclusive licensee in China, Ocumension Therapeutics,has received positive pre-submission regulatory feedback from the Chinese Center for DrugEvaluation for NCX 470. Ocumension considers the feedback is sufficient to proceed withthe submission of the dossier for marketing approval of NCX 470 to the Chinese NationalInstitutes for Food and Drug Control. NCX 470 (bimatoprost grenod) is a novel nitric oxidedonating bimatoprost eye drop for lowering intraocular pressure in patients with open-angleglaucoma or ocular hypertension.
“We congratulate our colleagues at Ocumension for the progress made on NCX 470 in China.This positive interaction with the Chinese Center for Drug Evaluation follows the recentlyannounced successful NCX 470 pre-New Drug Application meeting with the U.S. FDA. Withthese two outcomes in hand, we are confident the respective submissions can be achievedshortly.” said Doug Hubatsch, Chief Scientific Officer of Nicox. “As previouslycommunicated, we expect that our exclusive U.S. partner, Kowa, will submit the New DrugApplication for NCX 470 in the U.S. this summer, and that the Chinese submission will followshortly afterwards.”
NCX 470 is licensed globally to Kowa, except in the Chinese market, South Korea andSoutheast Asia, where it is licensed to Ocumension Therapeutics. Nicox mayreceive regulatory and sales milestones and will be paid royalties on worldwide sales. Allregulatory and commercialisation costs are borne by Kowa and Ocumension.
Key Future Milestones
• NCX 470 NDA submission in the United States: expected in summer 2026
• NCX 470 NDA submission in China: expected shortly after submission in the U.S.
• NCX 470 Phase 3 clinical program in Japan: initiated in summer 2025.
About Nicox
Nicox SA is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocularhealth. Nicox’s lead late-stage development program is NCX 470 (bimatoprost grenod), a novel nitric oxide-donatingbimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension, licensedto Ocumension Therapeutics for the Chinese, Korean and Southeast Asian markets and to Kowa in the rest of the world. Nicoxalso has a preclinical research program on NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, withGlaukos. Nicox’s first product, VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, is availablecommercially in the U.S. and over 15 other territories. Nicox generates revenue from ZERVIATE® in allergic conjunctivitis,licensed in multiple geographies, including to Harrow, Inc. in the U.S., and Ocumension Therapeutics in the Chinese and in themajority of Southeast Asian markets.