Nicox announced that it has received positive written feedback from its pre-new drug application (NDA) meeting with the FDA for NCX 470, its investigational therapy for IOP.
According to the meeting minutes, the FDA confirmed that the current data package, as well as the proposed content and format of the NDA submission, are generally acceptable for filing. The agency requested additional pharmacokinetic data, which will be generated in a small number of patients as part of an ongoing clinical study in Japan. Nicox stated that this request will not affect the planned regulatory timeline, with the NDA submission remaining on track for summer 2026.
NCX 470 (bimatoprost grenod) is a novel nitric oxide-donating bimatoprost eye drop designed to lower IOP in patients with open-angle glaucoma or ocular hypertension.
“The productive and collaborative pre-NDA meeting with the FDA was conducted with our partner Kowa,” said Doug Hubatsch, EVP and Chief Scientific Officer of Nicox. “The outcome supports the finalization of our registration dossier with its comprehensive data package, including positive results from two phase 3 studies, and facilitates proceeding with submitting the NCX 470 new drug application to the U.S. Food and Drug Administration. Nicox will now transfer ownership of the application to Kowa to make the submission as planned in the summer of 2026.”
NCX 470 is licensed globally to Kowa, except in China, South Korea and Southeast Asia, where rights are held by Ocumension Therapeutics. Under the terms of the licensing agreements, Nicox may receive regulatory and sales milestone payments, as well as royalties on worldwide sales. All regulatory and commercialization expenses will be borne by Kowa and Ocumension.
Key Future Milestones
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NCX 470 NDA submission in the United States: Expected summer 2026
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NCX 470 NDA submission in China: Expected shortly after U.S. submission
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NCX 470 Phase 3 clinical program in Japan: Initiated summer 2025
