Nicox Targets China's Vast Glaucoma Market with Novel Drug Filing

SOPHIA ANTIPOLIS, France – August 10, 2026 – French ophthalmology specialist Nicox SA has taken a pivotal step in its global expansion strategy, announcing today that its partner, Ocumension Therapeutics, has submitted a New Drug Application (NDA) in China for its lead asset, NCX 470. The filing with China's National Medical Products Administration (NMPA) seeks approval for the novel eye drop to lower intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, positioning the treatment to enter one of the world's largest and fastest-growing healthcare markets.

The submission marks a critical milestone not only for Nicox's innovative nitric oxide (NO)-donating technology but also for the strategic partnership that underpins its ambitions in Asia. With parallel regulatory reviews underway in major global territories, NCX 470 is on a trajectory to become a significant new option for millions of patients at risk of irreversible vision loss.

A Blueprint for Market Entry

The successful NDA submission in China is the culmination of a long-standing and carefully structured collaboration between Nicox and Ocumension, a partnership that serves as a case study for Western biotechs navigating the complexities of the Chinese pharmaceutical landscape. The alliance, initiated in 2018 when Ocumension was a newly formed entity, has proven to be a powerful vehicle for advancing NCX 470.

Under the terms of their agreement, Ocumension holds exclusive rights to develop and commercialize the drug in China, Korea, and Southeast Asia. The financial architecture of the deal highlights a deep, shared commitment: Ocumension has already paid Nicox €18 million in license fees and is a principal shareholder in the French company. Furthermore, it shared 50% of the costs for the pivotal Denali Phase 3 trial. Upon commercialization, Nicox stands to receive tiered royalties ranging from 6% to 12% on net sales in the region.

"Nicox and Ocumension have been successfully collaborating since 2018 when we signed the first of multiple licensing deals between the two companies," said Gavin Spencer, Chief Executive Officer of Nicox. "We are pleased to see that the confidence shown by both sides has been borne out with this next step on the way to the commercialisation of NCX 470 in China."

Crucially, Ocumension is not just a financial partner but a commercial powerhouse in the region. The company already markets Nicox’s allergic conjunctivitis treatment, ZERVIATE, and has built a formidable ophthalmology sales force across China. This established infrastructure is expected to facilitate a rapid and effective launch of NCX 470 following regulatory approval.

"Our established commercial operation in China... is well-placed to launch this novel glaucoma treatment shortly after approval," affirmed Victor Liu, Chief Executive Officer of Ocumension. "We look forward to continuing to work together as we bring NCX 470 to the Chinese market."

A Novel Approach to a Growing Health Challenge

At the heart of this strategic push is a significant therapeutic innovation. NCX 470 is a novel, dual-action eye drop that combines bimatoprost, a well-established prostaglandin analog (PGA), with Nicox's proprietary nitric oxide-donating technology. PGAs are the current first-line treatment for glaucoma, but NCX 470 is designed to offer superior IOP reduction by leveraging a second mechanism of action.

When administered, the drug releases both bimatoprost and nitric oxide. While bimatoprost increases fluid outflow through one pathway, the NO molecule activates a separate pathway, enhancing aqueous humor drainage through the trabecular meshwork. This dual mechanism, demonstrated in the positive Phase 3 Mont Blanc and Denali trials, offers the potential for more effective pressure control, a critical factor in preventing the progression of glaucomatous optic nerve damage.

The potential market for such an innovation in China is immense. The country's ophthalmic drug market was valued at over USD 2.3 billion in 2025 and is projected to more than double by 2033, driven by an aging population and rising disease prevalence. Estimates suggest China could be home to as many as 24 million glaucoma patients, with millions more affected by ocular hypertension. The unmet need is significant, as current guidelines point to challenges with patient adherence to multi-drug regimens and side effects from preservatives common in older formulations.

NCX 470 enters a competitive but evolving market. While dominated by PGAs, recent approvals like Santen Pharmaceutical's preservative-free combination therapy signal a demand for more advanced and patient-friendly options. As a next-generation, single-molecule therapy with a novel mechanism, NCX 470 is well-positioned to capture a meaningful share of this expanding market.

Navigating the Path to Global Commercialization

The Chinese NDA filing is a key pillar in Nicox’s broader global strategy for NCX 470. It follows a recent submission in the United States by Nicox's partner for the rest of the world, Kowa, with a decision from the U.S. FDA expected in the summer of 2027. Simultaneously, Phase 3 trials to support a regulatory submission in Japan have been underway since the summer of 2025. This multi-pronged approach diversifies risk and maximizes the drug's global commercial potential.

The path to approval in China was streamlined by strategic foresight. Nicox and Ocumension proactively included clinical sites in China as part of the global Denali trial. This allowed the same robust data package used for the U.S. submission to be filed with the NMPA, potentially accelerating the review process. While there is no fixed approval timeline in China, regulatory experts note that a 12-to-18-month review period is common for such applications, aligning with the company's expectations.

"NDAs for NCX 470 have now been submitted in two major territories, the United States and China, and Phase 3 trials to support a regulatory submission in Japan have been underway since summer 2025," Spencer noted. "NCX 470 is on the way to multiple approvals and launches over the next 12 to 24 months."

This series of regulatory and commercial milestones validates Nicox's nitric oxide-donating research platform, which has already produced the commercialized glaucoma drug VYZULTA®. With the anticipated launch of NCX 470 in the U.S. in the second half of 2027 and a subsequent launch in China, Nicox and its partners are poised to deliver a transformative new treatment to the global ophthalmology market.