FDA Accepts Nicox's NCX 470 NDA for Glaucoma, Sets PDUFA Date
The FDA has accepted Nicox's NDA for NCX 470, a nitric oxide-donating bimatoprost eye drop for glaucoma and ocular hypertension, with a PDUFA date of April 30, 2027. The application is supported by phase 3 trials showing IOP reductions up to 10 mmHg, and a US launch is targeted for the second half of 2027.
The US Food and Drug Administration (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 intraocular pressure (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 application 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 the Denali trial, the study met its primary objective of non-inferiority in lowering IOP from baseline compared to latanoprost (7.9 to 10.0 mmHg vs 7.1 to 9.8 mmHg, respectively). The NDA for NCX 470, which combines bimatoprost with nitric oxide donation, was also submitted in China in August 2026, and a phase 3 clinical program is ongoing in Japan.
"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," the CEO of Nicox said in a company announcement. If the FDA approves the NDA, Nicox would receive a milestone payment from Kowa and would be eligible for royalties on future sales. Nicox is working with Kowa in the United States and Ocumension in China on potential commercialization, subject to regulatory approvals.