Montgomery, Alabama, United States, Aug. 27, 2026
Kowa Pharmaceuticals America, Inc. (KPA) announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for K-911 (bimatoprost grenod), also known as NCX 470, an investigational once-daily ophthalmic treatment being developed to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2027, marking an important regulatory milestone for the investigational therapy. K-911 is a topical ophthalmic monotherapy formulated as a sterile solution and designed to lower IOP through two distinct aqueous humor outflow pathways. The application is supported by results from two pivotal Phase 3 clinical trials, Mont Blanc and Denali, which evaluated K-911 0.1% against latanoprost 0.005%, a widely used prostaglandin analog. Kowa stated that, subject to FDA approval, it anticipates a potential U.S. commercial launch in the second half of 2027.
K-911 Uses Dual Mechanism to Lower IOP
K-911 is designed as a nitric oxide-donating bimatoprost eye drop, combining the activity of bimatoprost with nitric oxide-mediated effects to target elevated IOP. The investigational therapy is intended to influence two separate pathways involved in aqueous humor drainage from the eye. Nitric oxide is designed to enhance conventional aqueous humor outflow through the trabecular meshwork–Schlemm’s canal pathway, while bimatoprost is intended to increase uveoscleral outflow. This dual-pathway approach is being investigated as a potential strategy for achieving effective IOP reduction with a once-daily topical formulation. Maintaining appropriate IOP control is a central component of glaucoma management because elevated pressure is a major risk factor associated with optic nerve damage and disease progression. K-911 remains investigational and has not been approved by the FDA, with the current NDA review representing the next stage in its U.S. regulatory development.
Phase 3 Trials Support Regulatory Submission
The K-911 NDA is supported by two pivotal Phase 3 studies, Mont Blanc and Denali, which compared the investigational treatment with latanoprost 0.005% in patients with open-angle glaucoma or ocular hypertension. The clinical program was designed to evaluate the IOP-lowering potential of K-911 in patient populations for whom controlling elevated IOP is an important treatment objective. The regulatory submission follows Kowa’s expansion of its rights to develop and commercialize K-911 in the United States and other licensed territories. Kowa Company, Ltd. and Nicox S.A. initially entered 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 candidate in the United States and other licensed territories. Nicox discovered and developed K-911 and led the Mont Blanc and Denali Phase 3 trials, while Kowa is responsible for U.S. regulatory and commercialization activities.
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FDA Review Advances Potential Glaucoma Treatment
The FDA’s acceptance of the NDA places K-911 into formal regulatory review and establishes a defined timeline for the agency’s decision. The potential therapy is being developed for open-angle glaucoma and ocular hypertension, conditions affecting millions of people and associated with elevated IOP. Glaucoma is a progressive eye disease that can cause irreversible optic nerve damage, vision loss and, in advanced cases, blindness. Open-angle glaucoma represents the most common form of glaucoma, while ocular hypertension involves elevated IOP without detectable optic nerve damage or vision loss and can increase the risk of developing glaucoma. For patients with these conditions, lowering IOP remains a key therapeutic goal. Kowa’s U.S. NDA submission therefore represents a significant development in the company’s ophthalmology strategy and could introduce an additional once-daily treatment option if the FDA determines that the application meets the required standards for safety and efficacy. With the April 30, 2027 PDUFA target action date, Kowa and the ophthalmology community will await the FDA’s regulatory decision on K-911.
Source: Kowa Pharmaceuticals press relese
