Nicox NCX 470 clears China pre-submission review ahead of dual NDA push

Nicox has confirmed that its Chinese licensee, Ocumension Therapeutics, received positive pre-submission feedback from China's Centre for Drug Evaluation (CDE) for NCX 470, the company's nitric oxide-donating bimatoprost eye drop for open-angle glaucoma and ocular hypertension. Ocumension said the feedback is sufficient to proceed with a formal New Drug Application to the Chinese National Institutes for Food and Drug Control.

The Chinese submission is expected to follow shortly after the US filing, which Nicox's American partner Kowa is targeting for summer 2026. Nicox disclosed earlier this year that Kowa had completed a successful pre-NDA meeting with the FDA, giving the French ophthalmology company two concurrent regulatory pathways advancing in parallel.

Dual-market filing strategy

NCX 470, known generically as bimatoprost grenod, works by combining a prostaglandin analogue with a nitric oxide-donating moiety, a mechanism the company argues produces additive intraocular pressure lowering. Nicox has structured its global licensing so that all regulatory and commercialisation costs fall to its partners: Kowa covers all markets outside China, South Korea and Southeast Asia, while Ocumension holds rights in those Asian territories. Nicox itself stands to receive regulatory milestones and royalties on eventual sales without bearing the direct filing costs.

Doug Hubatsch, chief scientific officer of Nicox, said the China interaction "follows the recently announced successful NCX 470 pre-New Drug Application meeting with the US FDA," adding that the company is confident both submissions can be achieved in close succession.

A Phase 3 clinical programme in Japan was initiated in summer 2025, suggesting Nicox and its partners are building toward a three-market regulatory presence across the US, China and Japan. The Japanese programme means investors should watch for interim data readouts alongside the NDA filings in the nearer term.

Market context

Glaucoma is a large and growing therapeutic area, driven by ageing populations across the US, Europe and Asia. The prostaglandin analogue class, which includes latanoprost and bimatoprost itself, is well-established as first-line treatment, meaning NCX 470 would need to demonstrate a meaningful clinical advantage over generic alternatives to gain significant market share. The nitric oxide-donating approach is a genuine differentiator, but the pivotal data underpinning the US NDA will be scrutinised closely by regulators and payers alike.

Nicox already has commercial precedent in the space: its first product, VYZULTA (latanoprostene bunod), also a nitric oxide-donating prostaglandin analogue, is marketed in the US and more than 15 other territories under a licence to Bausch + Lomb. That relationship gives Nicox a reference point in regulatory interactions for this class of molecule, which may support the CDE's positive disposition toward NCX 470's dossier. The company also generates revenue from ZERVIATE in allergic conjunctivitis across multiple geographies, providing some commercial stability as NCX 470 approaches the filing stage.