The U.S. Food and Drug Administration (FDA) has accepted Kowa Pharmaceuticals America’s New Drug Application (NDA) for K-911, an investigational eye drop being developed to reduce elevated eye pressure in patients with open-angle glaucoma and ocular hypertension.
The FDA has set April 30, 2027, as the Prescription Drug User Fee Act (PDUFA) target action date for the application.
K-911, also known as bimatoprost grenod or NCX 470, is a once-daily topical treatment designed to lower intraocular pressure (IOP) through two different pathways. The medicine combines bimatoprost with a nitric oxide-donating component.
Nitric oxide is designed to improve the conventional drainage of fluid through the trabecular meshwork and Schlemm’s canal, while bimatoprost works by increasing fluid drainage through the uveoscleral pathway. By targeting both pathways, Kowa believes K-911 could offer another option for managing elevated IOP.
The NDA is supported by results from two Phase 3 studies, Mont Blanc and Denali. The trials evaluated K-911 0.1% against latanoprost 0.005%, a commonly used prostaglandin-based glaucoma treatment, in patients with open-angle glaucoma or ocular hypertension.
Controlling intraocular pressure is a key part of glaucoma management because elevated pressure can damage the optic nerve and lead to vision loss. Patients may require long-term treatment, and response to available therapies can differ between individuals.
Joe Barna, CEO and President of Kowa Pharmaceuticals America, said the FDA’s acceptance of the NDA represents an important step toward potentially providing a new treatment option for people with open-angle glaucoma and ocular hypertension.
K-911 was originally discovered and developed by Nicox S.A., which also conducted the Mont Blanc and Denali Phase 3 trials. Kowa and Nicox entered into an exclusive licensing agreement in February 2024 covering development, manufacturing and commercialization of K-911 in Japan.
In July 2025, Kowa obtained rights to develop and commercialize the drug in the United States and other licensed territories. Nicox continues to provide development support and expertise, while Kowa is responsible for U.S. regulatory and commercial activities.
The acceptance of the NDA means the FDA will now conduct a full review of the application. Kowa expects to launch K-911 commercially in the United States in the second half of 2027 if the FDA approves the treatment.
The upcoming regulatory decision will determine whether K-911 can become a new once-daily treatment for reducing elevated intraocular pressure in people with glaucoma and ocular hypertension.