Nicox: PDUFA date set for the NCX 470 in April 2027

Nicox SA announced that the FDA has set April 30, 2027, as the date for the Prescription Drug User Fee Act (PDUFA) approval of its glaucoma medication, NCX 470. This milestone marks a significant regulatory advancement for the ophthalmology company. The Drug User Fee Act (DNA) application was submitted by Nicox's exclusive US partner, Kowa, on June 30, 2026. Upon approval, a milestone payment will be made, followed by royalties on sales.

NCX 470 is an innovative eye drop solution combining bimatoprost and a nitric oxide donor, designed to reduce intraocular pressure in patients with open-angle glaucoma. Phase 3 clinical trials in Mont Blanc and Denali demonstrated a significant reduction in intraocular pressure, up to 10 mmHg. Nicox anticipates a commercial launch in the United States in the second half of 2027, subject to FDA approval, and hopes for similar launches in China with its partner Ocumension.