FDA Accepts Filing of Kowa's K-911 for Glaucoma Treatment

Kowa Company, Ltd., based in Nagoya, Japan, has announced that its New Drug Application (NDA) for K-911 has been accepted by the U.S. Food and Drug Administration (FDA). K-911 targets intraocular pressure reduction in patients with glaucoma and ocular hypertension. The application was submitted on June 30, 2026, and the FDA's review is underway with an action date set for April 30, 2027, under the Prescription Drug User Fee Act.

K-911, or bimatoprost grenod, is a novel drug combining nitric oxide donation and is developed by Nicox S.A., a French pharmaceutical company. Kowa has an exclusive license agreement with Nicox for development and commercialization in various regions. K-911 lowers intraocular pressure by promoting aqueous humor outflow through distinct pathways.

Kowa aims to offer a new therapeutic option for patients by promoting K-911's effective intraocular pressure-lowering effects.