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 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 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.

Mr. Spencer noted that NDAs for NCX 470 have now been submitted in the United States and China. Nicox is working with Kowa in the United States and Ocumension in China on potential commercialization, subject to regulatory approvals. If the FDA approves the NDA, Nicox would receive a milestone payment from Kowa and would be eligible for royalties on future sales. 

Beyond the US regulatory review, development and regulatory activities for NCX 470 are continuing internationally. A phase 3 clinical program is ongoing in Japan, and an NDA was submitted in China in August 2026.