New Drug Application for "K-911" Targeting Patients with Glaucoma and Ocular Hypertension Accepted for Filing in the U.S., Food and Drug Administration

NAGOYA, Japan, Aug. 27, 2026 /PRNewswire/ --  Kowa Company, Ltd. (hereafter referred to as "Kowa") is developing K-911 for the indication of reducing intraocular pressure (IOP) in patients with glaucoma or ocular hypertension through its affiliated company engaged in pharmaceutical development in the United States, Kowa Research Institute, Inc. (headquartered in North Carolina, USA). Kowa today announced that the New Drug Application (NDA) submitted to the U.S. Food and Drug Administration (FDA) on June 30, 2026 has been accepted for filing. The FDA will conduct its review of the NDA with a target action date of April 30, 2027, under the Prescription Drug User Fee Act (PDUFA).

K-911 (bimatoprost grenod) is a novel prostanoid FP receptor agonist including the moiety donating nitric oxide (NO), discovered by Nicox S.A. (hereafter referred to as "Nicox"), a French pharmaceutical company focused on the research and development of ophthalmic prescription drugs. Kowa entered into an exclusive license agreement with Nicox for development, manufacturing, and commercialization in Japan in February 2024, and for the rest of the world excluding China, Taiwan, Korea, and Southeast Asia in July 2025.

"K-911" has demonstrated a potent IOP-lowering effect by promoting aqueous humor outflow through two pathways: the conventional outflow pathway via the trabecular meshwork–Schlemm's canal mediated by NO, and the unconventional outflow pathway via the uveoscleral mediated by bimatoprost.

Through the development of K-911, Kowa aims to provide a new treatment option for patients with glaucoma and ocular hypertension.

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