The US Food and Drug Administration (FDA) has accepted Kowa Pharmaceuticals America’s New Drug Application (NDA) for K-911 (bimatoprost grenod; NCX 470), an investigational once-daily eye drop designed to lower intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
The agency has assigned a Prescription Drug User Fee Act target action date of April 30, 2027.
K-911 is a nitric oxide-donating bimatoprost monotherapy intended to reduce IOP through two aqueous humor outflow pathways. The nitric oxide component is designed to increase conventional outflow through the trabecular meshwork-Schlemm’s canal pathway, while bimatoprost increases uveoscleral outflow.
The NDA is supported by two pivotal Phase III trials, Mont Blanc and Denali, which compared K-911 0.1% with latanoprost 0.005% in patients with open-angle glaucoma or ocular hypertension. Latanoprost is a commonly prescribed prostaglandin analog used to reduce IOP.
Lowering IOP remains the only proven approach for slowing glaucoma progression, making sustained pressure control a central treatment goal. However, treatment requirements can change over time, and some patients need additional or alternative therapies to reach target IOP.
“The FDA’s acceptance of the NDA for K-911 marks an important milestone as we work toward bringing a potential new treatment option to people living with open-angle glaucoma or ocular hypertension,” said Joe Barna, president and CEO of Kowa Pharmaceuticals America. Barna added that the company looks forward to working with the FDA as the review process progresses.
K-911 was discovered and developed by Nicox, which also led the Mont Blanc and Denali trials, and continues to provide development support. Kowa Company and Nicox entered an exclusive licensing agreement covering Japan in 2024, followed by a 2025 agreement granting Kowa development and commercialization rights in the US and other territories. Kowa is now responsible for US regulatory and commercialization activities.
K-911 remains investigational and has not been approved by the FDA. If approved, Kowa said it anticipates launching the treatment in the US in the second half of 2027.
Source: PR Newswire.
