NicOx S.A.FDA accepted NDA and set PDUFA date for NCX 470, a key regulatory milestone
Nicox SA announced that the U.S. Food and Drug Administration has accepted the New Drug Application for NCX 470, a nitric oxide-donating bimatoprost eye drop for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension, and set 30 April 2027 as the Prescription Drug User Fee Act (PDUFA) date for a response on review of the dossier. The NDA was submitted by Nicox's exclusive U.S. licensee, Kowa, on June 30, 2026, and a milestone payment will be due upon approval. NCX 470 NDAs are now filed in two key markets, the U.S. and China, with commercial partners Kowa and Ocumension in place for expected launches from H2 2027 onwards. The submission was based on positive results from the Mont Blanc and Denali Phase 3 trials, which demonstrated clinically meaningful reductions in IOP of up to 10 mmHg with a favorable safety profile. A Phase 3 program is ongoing in Japan, and a Q&A is available on Nicox's website.
NicOx S.A.FDA accepted NDA and set PDUFA date for NCX 470, a key regulatory milestone
FDA accepted NDA and set PDUFA date for NCX 470, a step toward approval and launch
Pfizer Inc