The US Food and Drug Administration (FDA) is set to review Kowa Pharmaceuticals America’s new drug application (NDA) for K-911, an investigational once-daily eye drop aimed at reducing intraocular pressure (IOP) in open-angle glaucoma (OAG) or ocular hypertension (OHT) patients.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of 30 April 2027.
Also known as bimatoprost grenod or NCX 470, K-911 is being developed as a topical ophthalmic monotherapy formulated as a sterile solution.
The treatment is designed to decrease IOP through two mechanisms: nitric oxide to boost outflow through the trabecular meshwork-Schlemm’s canal, and bimatoprost to increase uveoscleral outflow.
The NDA is supported by data from two pivotal Phase III trials, Mont Blanc and Denali, in which K-911 0.1% was compared with latanoprost 0.005%, an established prostaglandin analogue, in individuals with OAG or OHT.
Kowa Pharmaceuticals America stated that achieving and maintaining IOP control remains a significant treatment goal in OAG and OHT, as individual patient needs can vary over time.
Kowa Pharmaceuticals America CEO and president Joe Barna said: “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.
“We’re proud to bring Kowa’s decades of global ophthalmology experience to the US eye care community, and we look forward to working with the FDA throughout the review process.”
In February 2024, Kowa Company and Nicox signed an exclusive licensing agreement for the development, manufacturing and commercialisation of K-911 in Japan.
An additional agreement in July 2025 granted Kowa the rights to develop and commercialise the product in the US and other regions.
Nicox, which discovered and developed K-911 and led the Phase III trials, will continue to provide development support while Kowa oversees regulatory and commercial activities in the US.
