Nicox’s partner Ocumension submits an NDA in China for NCX 470, a nitric oxide-donating bimatoprost eye drop to lower IOP in glaucoma.
Written By: Kalyani Boharapi,
M.Pharm (Reg. Affairs)
Reviewed By: Pharmacally Editorial Team
Nicox has announced that its exclusive licensee in China, Ocumension Therapeutics, has submitted a New Drug Application (NDA) for NCX 470 to the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). The application seeks approval of NCX 470 to lower intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
NDA Supported by Phase 3 Clinical Program
The Chinese NDA includes data from the Phase 3 Mont Blanc (NCT04445519) and Denali (NCT04630808) clinical trials. The Denali trial included clinical sites in China, allowing the program to complete the clinical requirements for approval in the country. Nicox said the Chinese submission uses the same data package recently submitted to the U.S. Food and Drug Administration (FDA).
Nicox said NDAs for NCX 470 have now been submitted in both the United States and China. In the U.S., Nicox’s partner Kowa recently submitted the NDA. Meanwhile, Phase 3 clinical trials supporting a future regulatory submission in Japan have been underway since summer 2025.
Established Partnership Supports Commercialization Plans
Nicox and Ocumension have been collaborating since 2018. Ocumension has previously obtained approval for several ophthalmology products in China and already markets Nicox’s ZERVIATE® in the country. The company also has an established ophthalmology sales force throughout China, which Nicox says positions it for a rapid launch of NCX 470 following regulatory approval.
According to Ocumension CEO Victor Liu, the established relationship between the two companies enabled the Chinese filing to proceed swiftly after the U.S. documentation became available. Ocumension’s existing commercial operation in China is expected to support the introduction of NCX 470 following regulatory approval.
Financial Terms of the Collaboration
Ocumension has paid Nicox €18 million in license fees for rights to develop and commercialize NCX 470 in China, Korea and Southeast Asia. Ocumension also contributed 50% of the costs of the Denali clinical trial and is one of Nicox’s principal shareholders. Nicox is eligible to receive tiered royalties ranging from 6% to 12% on NCX 470 sales made by Ocumension.
About NCX 470
NCX 470 is a novel nitric oxide (NO)-donating bimatoprost eye drop that combines Nicox’s proprietary NO-donating research platform with bimatoprost in a single molecule. It is designed to release both bimatoprost and NO into the eye to lower IOP through two different pathways.
According to Nicox, NO is a naturally occurring signaling molecule involved in the regulation of IOP through activation of soluble guanylate cyclase (sGC). The NO component is intended to provide additional IOP-lowering activity by enhancing aqueous humor drainage through a mechanism different from that of prostaglandin analogs.
Positive Phase 3 Results Support Global Regulatory Filings
NCX 470 has completed two Phase 3 clinical trials, Mont Blanc and Denali, which were designed to fulfill regulatory requirements for safety and efficacy in support of NDA submissions in the United States and China. Nicox said both trials were positive and met the efficacy endpoints required for regulatory submission.
Regulatory and Commercial Outlook
Nicox expects several regulatory and commercial milestones for NCX 470 over the coming years. The company expects a U.S. NDA approval in summer 2027, based on a standard 12-month review period, with a U.S. launch expected in the second half of 2027.
China does not have a fixed pharmaceutical approval timeline, although approvals are frequently granted within 12 to 18 months following submission. Nicox expects approval of NCX 470 in China after U.S. approval. The Phase 3 clinical program in Japan, which began in summer 2025, is continuing to support a future regulatory submission.
The China NDA marks the second major regulatory submission for NCX 470, following the U.S. filing, while clinical development continues in Japan toward a future regulatory submission.
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About the Writer
Kalyani Boharapi (LinkedIn) is a pharmacy professional and healthcare writer currently pursuing an M.Pharm in Regulatory Affairs at Dr. D. Y. Patil College of Pharmacy, with interests in pharmaceutical regulations, drug development, and healthcare innovation. She has academic exposure to dossier preparation, scientific writing, and regulatory documentation. Kalyani has also completed certification courses in Generative AI, AI in Pharma, and Bioinformatics, and actively participates in pharmaceutical conferences to stay updated with emerging trends and advancements in the healthcare and pharmaceutical industry.