Representational image (credit: Magnific)
The US Food and Drug Administration (FDA) has accepted for review Kowa Pharmaceuticals America’s (KPA) New Drug Application (NDA) for K-911 (bimatoprost grenod, also known as NCX 470), an investigational topical ophthalmic monotherapy for reducing 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.
Glaucoma is a progressive eye disease that can cause irreversible optic nerve damage, leading to vision loss and potentially blindness. Open-angle glaucoma is the most common form of the disease. Lowering IOP is the only proven approach to slowing the progression of glaucoma.
Ocular hypertension is characterised by elevated IOP without detectable optic nerve damage or vision loss. Although OHT may not cause symptoms, elevated IOP is an important risk factor for developing glaucoma.
Despite the availability of multiple treatment options, achieving and maintaining appropriate IOP control remains an important treatment goal for patients with OAG or OHT, with individual treatment needs varying from patient to patient and over time.
“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, CEO and President of KPA.
K-911 is an investigational, once-daily nitric oxide-donating bimatoprost eye drop designed to lower intraocular pressure through two distinct aqueous humour outflow pathways. Nitric oxide is intended to enhance conventional outflow through the trabecular meshwork-Schlemm’s canal pathway, while bimatoprost enhances uveoscleral outflow.
The NDA is supported by two pivotal Phase 3 clinical trials, Mont Blanc and Denali, which evaluated K-911 0.1% against latanoprost 0.005%, a widely used prostaglandin analogue, in patients with OAG or OHT.
In February 2024, Kowa Company and Nicox S.A. entered into an exclusive licensing agreement for the development, manufacturing and commercialisation of K-911 in Japan. In July 2025, the companies entered into a further agreement granting Kowa rights to develop and commercialise K-911 in the US and other licensed territories.
Nicox, which discovered and developed K-911 and led the Mont Blanc and Denali Phase 3 trials, continues to provide development expertise and support, while Kowa is responsible for US regulatory and commercialisation activities.
The FDA’s acceptance of the K-911 NDA for filing marks the latest regulatory milestone for the product in the US as the application proceeds through FDA review.
Following confirmation of the PDUFA target action date of April 30, 2027, Kowa anticipates a US commercial launch in the second half of 2027, subject to FDA approval.
