NCX 470 gains positive regulatory feedback in China ahead of US NDA submission

Nicox has announced that its exclusive licensee in China, Ocumension Therapeutics, received positive pre-submission regulatory feedback from the Chinese Center for Drug Evaluation for NCX 470.¹ According to the company, Ocumension considers the feedback sufficient to proceed with submitting the dossier for marketing approval of NCX 470 to the Chinese National Institutes for Food and Drug Control.

The announcement is the second favorable regulatory signal for the candidate in a matter of months and arguably the more consequential of the pair from a market-access standpoint. For a chronic, lifelong therapy such as glaucoma treatment, a clear regulatory runway in China—home to one of the largest populations of patients with open-angle glaucoma in the world—represents a meaningful expansion of the commercial opportunity that has, until now, been framed largely around the US filing.

NCX 470 is a novel nitric oxide (NO)–donating bimatoprost eye drop that leverages the IOP-lowering effects of NO and prostaglandin analogs (PGAs), releasing both bimatoprost and NO into the eye to lower IOP through 2 distinct pathways in patients with open-angle glaucoma or ocular hypertension. The molecule incorporates Nicox's proprietary NO-donating research platform and bimatoprost in a single agent, the differentiator the company has consistently positioned at the center of the program.

"We congratulate our colleagues at Ocumension for the progress made on NCX 470 in China," said Doug Hubatsch, chief scientific officer of Nicox, in a company news release.¹ "This positive interaction with the Chinese Center for Drug Evaluation follows the recently announced successful NCX 470 pre–New Drug Application meeting with the US FDA. With these 2 outcomes in hand, we are confident the respective submissions can be achieved shortly." Hubatsch added that the company continues to expect its exclusive US partner, Kowa, to submit the New Drug Application (NDA) for NCX 470 in the US this summer, with the Chinese submission following shortly afterward.

The China feedback builds on a positive pre-NDA meeting with the US FDA earlier this year, at which the agency indicated that the proposed data package and the content and format of the planned submission were generally acceptable for filing—keeping the US NDA on track for summer 2026. That outcome itself rested on a maturing late-stage data set, with Nicox previously confirming it had acquired and analyzed the key data required to support NDA submissions in both the US and China.

The clinical foundation for both filings comes from a 2-trial pivotal program. In its topline readout from the phase 3 Denali trial, NCX 470 0.1% met its primary endpoint of non-inferiority to latanoprost 0.005% in lowering IOP from baseline, with an IOP-lowering effect of 7.9 to 10.0 mm Hg versus 7.1 to 9.8 mm Hg for latanoprost.² The randomized, multiregional, double-masked, parallel-group study evaluated NCX 470 against latanoprost in 696 patients across 90 sites in the US and China, and completed treatment and follow-up visits in June 2025.³ Denali, together with the earlier Mont Blanc phase 3 trial—which also met its primary objective of non-inferiority to latanoprost—was designed to fulfill the clinical regulatory requirements supporting NDA submissions in the US and China.⁴

The commercial architecture around NCX 470 reflects a deliberate division of territory and risk. The candidate is licensed globally to Kowa, except in the Chinese market, South Korea, and Southeast Asia, where it is licensed to Ocumension Therapeutics.⁵ Under those agreements, Nicox may receive regulatory and sales milestones and is paid royalties on worldwide sales, while all regulatory and commercialization costs are borne by Kowa and Ocumension—a structure that lets the comparatively small developer participate in 2 major markets without shouldering the spend.

Per Nicox, the key future milestones are as follows:

• NCX 470 NDA submission in the United States: expected in summer 2026
• NCX 470 NDA submission in China: expected shortly after the US submission
• NCX 470 phase 3 clinical program in Japan: initiated in summer 2025

With positive feedback now in hand on both sides of the Pacific, the coming months will test whether the program can convert favorable regulatory dialogue into filed applications on the timeline management has laid out.

References:

1. Nicox announces positive pre-submission regulatory feedback in China supporting NDA filing for NCX 470. Nicox SA. Published June 18, 2026. Accessed June 19, 2026.

2. Harp MD. Nicox releases topline data from phase 3 Denali trial of NCX 470 in open-angle glaucoma or ocular hypertension patients. Ophthalmology Times. Published August 21, 2025. Accessed June 19, 2026. https://www.ophthalmologytimes.com/view/nicox-releases-topline-data-from-phase-3-denali-trial-of-ncx-470-in-open-angle-glaucoma-or-ocular-hypertension-patients

3. Nicox completes phase 3 Denali trial of NCX 470 in open-angle glaucoma or ocular hypertension. Ophthalmology Times. Accessed June 19, 2026. https://www.ophthalmologytimes.com/view/nicox-completes-phase-3-denali-trial-of-ncx-470-in-open-angle-glaucoma-or-ocular-hypertension

4. Mont Blanc phase 3 glaucoma trial for NCX 470 achieves primary objective. Ophthalmology Times. Published February 19, 2026. Accessed June 19, 2026. https://www.ophthalmologytimes.com/view/mont-blanc-phase-3-glaucoma-trial-for-ncx-470-achieves-primary-objective

5. Nicox and Kowa sign agreement for exclusive rights to glaucoma treatment NCX 470. Ophthalmology Times. Accessed June 19, 2026. https://www.ophthalmologytimes.com/view/nicox-and-kowa-sign-agreement-for-exclusive-rights-to-glaucoma-treatment-ncx-470