Kowa Pharmaceuticals America said the FDA has accepted for review its New Drug Application for K-911, an investigational once-daily eye drop intended to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
The FDA assigned a Prescription Drug User Fee Act target action date of April 30, 2027. If approved, Kowa expects to launch the product in the United States during the second half of 2027.
K-911, also known as bimatoprost grenod or NCX 470, is a sterile topical ophthalmic monotherapy formulated as a nitric oxide-donating bimatoprost eye drop. The candidate is designed to reduce elevated intraocular pressure, or IOP, through two aqueous-humor outflow pathways.
Nitric oxide is intended to enhance conventional outflow through the trabecular meshwork and Schlemm’s canal pathway. Bimatoprost is intended to increase uveoscleral outflow.
The NDA is supported by two pivotal Phase 3 trials, Mont Blanc and Denali. The studies compared K-911 0.1% with latanoprost 0.005%, a prostaglandin analog, in patients with open-angle glaucoma or ocular hypertension.
Kowa did not disclose specific efficacy or safety data from the trials in its announcement. The company said that although multiple treatment options are available, achieving and maintaining appropriate IOP control remains a significant treatment goal, with patient needs varying over time.
Joe Barna, chief executive officer and president of Kowa Pharmaceuticals America, said acceptance of the application marks an important milestone toward bringing a potential new treatment option to people with open-angle glaucoma or ocular hypertension.
Kowa Company Ltd. entered an exclusive agreement with Nicox in February 2024 covering development, manufacturing and commercialization of K-911 in Japan. In July 2025, the companies expanded their relationship through an agreement granting Kowa rights to develop and commercialize K-911 in the United States and other licensed territories.
Nicox discovered and developed K-911 and led the Mont Blanc and Denali Phase 3 studies. It will continue to provide development expertise and support, while Kowa is responsible for U.S. regulatory and commercialization activities.
The FDA’s acceptance begins the formal review process but does not guarantee approval. Kowa will work with the agency as it evaluates the application ahead of the April 2027 action date.
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