Key Takeaways

  • The FDA has accepted the NDA for NCX 470 for lowering IOP in patients with open-angle glaucoma or ocular hypertension and set April 30, 2027, as the PDUFA target date
  • The application is supported by the phase 3 Mont Blanc and Denali trials, which Nicox said demonstrated IOP reductions of up to 10 mm Hg with a favorable safety profile
  • Nicox partner Kowa is targeting a US launch in the second half of 2027 if NCX 470 receives FDA approval

The FDA has accepted the new drug application (NDA) for Nicox's NCX 470 (bimatoprost grenod), a nitric oxide-donating bimatoprost eye drop being developed to lower IOP in patients with open-angle glaucoma or ocular hypertension,

The agency set April 30, 2027, as the Prescription Drug User Fee Act (PDUFA) target date for its decision on the application. FDA acceptance indicates that the NDA is sufficiently complete to proceed to formal review but does not constitute approval of the investigational therapy.

Kowa, Nicox's exclusive US licensee for NCX 470, submitted the NDA on June 30, 2026. The drug candidate is known as K-911 in Kowa’s publications.

"The FDA's acceptance of the NCX 470 NDA for filing is the next key step towards the approval of NCX 470 in the US, which would lead to a commercial launch in the second half of 2027," Gavin Spencer, CEO of Nicox, said in a company announcement.

"The FDA's acceptance of the NDA for K-911 marks an important milestone as we work toward bringing a potential new treatment option to people living with open-angle glaucoma or ocular hypertension," said Joe Barna, CPA, Chief Executive Officer and President of Kowa Pharmaceuticals. "We're proud to bring Kowa's decades of global ophthalmology experience to the U.S. eye care community, and we look forward to working with the FDA throughout the review process."

The NDA for NCX 470, which combines bimatoprost with nitric oxide donation, is supported by results from the phase 3 Mont Blanc and Denali clinical trials. Together, the studies were designed to satisfy efficacy and safety requirements supporting regulatory applications in the United States and China. According to Nicox, the trials demonstrated clinically meaningful IOP reductions of up to 10 mm Hg with a favorable safety profile.

In February 2024, Kowa and Nicox S.A. entered into an exclusive licensing agreement for the development, manufacturing and commercialization of K-911/NCX 470 in Japan, followed by an agreement in July 2025 granting Kowa rights to develop and commercialize K-911/NCX 470 in the United States and other licensed territories. Nicox, which discovered and developed K-911/NCX 470 and led the Mont Blanc and Denali Phase 3 trials, continues to provide development expertise and support, while Kowa is responsible for U.S. regulatory and commercialization activities.