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08.27.2026

FDA Accepts Nicox's NDA for NCX 470 for Glaucoma and OIcular Hypertension

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.

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