Key Takeaways

  • Ocumension Therapeutics has submitted an NDA in China for NCX 470 to lower IOP in patients with open-angle glaucoma or ocular hypertension
  • The application is supported by the phase 3 Mont Blanc and Denali trials and uses the same clinical dossier prepared for the US NDA submission
  • NCX 470 is now under regulatory consideration in the United States and China, while phase 3 development to support a potential Japanese filing is underway

Nicox announced that its exclusive licensee in China, Ocumension Therapeutics, has submitted a new drug application (NDA) for NCX 470 to China’s Center for Drug Evaluation of the National Medical Products Administration.The application seeks approval of NCX 470 for lowering IOP in patients with open-angle glaucoma or ocular hypertension.

NCX 470 is an investigational nitric oxide-donating bimatoprost eye drop designed to lower IOP through the combined activity of nitric oxide and the prostaglandin analog bimatoprost.

According to Nicox, the Chinese NDA incorporates data from the phase 3 Mont Blanc and Denali trials. The Denali study included clinical sites in China, enabling the development program to meet clinical requirements for a regulatory application in the country. The submission uses the same clinical dossier recently submitted to the FDA in the United States, the company said.

“Nicox and Ocumension have been successfully collaborating since 2018 when we signed the first of multiple licensing deals between the two companies,” Gavin Spencer, chief executive officer of Nicox, said in a statement. “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."

NCX 470 incorporates Nicox’s nitric oxide-donating technology and bimatoprost in a single molecule. It is designed to release both bimatoprost and nitric oxide in the eye, targeting IOP through 2 pathways.

Nitric oxide promotes aqueous humor drainage through activation of soluble guanylate cyclase and provides a mechanism of action distinct from that of prostaglandin analogs.

The Mont Blanc and Denali phase 3 trials were designed to provide the safety and efficacy evidence required to support regulatory submissions in the United States and China. According to Nicox, both studies met the efficacy endpoints required to support the applications.

The China filing follows a recent US NDA submission for NCX 470 by Nicox partner Kowa. Nicox said it expects a US regulatory decision in summer 2027 based on a standard 12-month review period, with a US commercial launch anticipated in the second half of 2027.

There is no fixed review period for pharmaceutical approvals in China, although Nicox said approvals are frequently granted within 12 to 18 months of submission. The company expects a potential Chinese approval to follow a US approval.

Development is also underway in Japan, where a phase 3 clinical program intended to support a future regulatory submission began in summer 2025.

Ocumension holds rights to develop and commercialize NCX 470 in China, Korea, and Southeast Asian markets. The company has paid Nicox €18 million in license fees and contributed 50% of the costs of the Denali trial. Under the licensing arrangement, Nicox is eligible for tiered royalties ranging from 6% to 12% on NCX 470 sales by Ocumension.