Key Takeaways

  • Ocumension Therapeutics received positive pre-submission feedback from China’s Center for Drug Evaluation for NCX 470, supporting advancement toward a marketing application filing
  • The regulatory update follows a successful pre-NDA meeting with the FDA and positions the program for near-term submissions in both the United States and China

Nicox announced that its exclusive China licensee, Ocumension Therapeutics, has received positive pre-submission regulatory feedback from the Chinese Center for Drug Evaluation (CDE) for NCX 470, a nitric oxide-donating bimatoprost eye drop under development for lowering IOP in patients with open-angle glaucoma or ocular hypertension.

According to Nicox, Ocumension believes the feedback is sufficient to support submission of the marketing application dossier for NCX 470 to the Chinese National Institutes for Food and Drug Control. The update follows a recently completed pre–new drug application (NDA) meeting with the US FDA that Nicox previously described as successful.

“We congratulate our colleagues at Ocumension for the progress made on NCX 470 in China,” Doug Hubatsch, chief scientific officer of Nicox, said in a company statement. “This positive interaction with the Chinese Center for Drug Evaluation follows the recently announced successful NCX 470 pre-new drug application meeting with the U.S. FDA. With these two outcomes in hand, we are confident the respective submissions can be achieved shortly.”

Hubatsch added that Nicox expects its exclusive US partner, Kowa, to submit the NDA for NCX 470 in the United States during the summer of 2026, with the Chinese submission anticipated shortly thereafter.

NCX 470 (bimatoprost grenod) combines bimatoprost with a nitric oxide–donating moiety and is being developed as a treatment to reduce IOP in patients with open-angle glaucoma or ocular hypertension. Elevated IOP remains the primary modifiable risk factor for glaucoma progression.

Under existing licensing agreements, Kowa holds global rights to NCX 470 outside of China, South Korea, and Southeast Asia, while Ocumension holds rights in those Asian territories. Nicox is eligible to receive regulatory and commercial milestone payments as well as royalties on worldwide sales. Development, regulatory, and commercialization expenses are being funded by Kowa and Ocumension under their respective agreements.

The company also highlighted ongoing development activities in Japan, where a phase 3 clinical program for NCX 470 was initiated in the summer of 2025.

Upcoming Milestones

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