FDA accepts Kowa’s K-911 glaucoma eye drop application for review
Kowa is seeking approval based on results from the pivotal Phase III Mont Blanc and Denali trials.
USA—The US Food and Drug Administration (FDA) has accepted Kowa Pharmaceuticals America’s new drug application (NDA) for K-911, an investigational once-daily eye drop designed to lower intraocular pressure (IOP) in people with open-angle glaucoma (OAG) or ocular hypertension (OHT).
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of 30 April 2027, when the agency is expected to complete its review and issue a decision on the application.
Dual mechanism of action
K-911, also known as bimatoprost grenod or NCX 470, is a topical ophthalmic formulation being developed as a once-daily monotherapy.
The sterile solution is designed to reduce IOP through two complementary mechanisms.
The treatment combines nitric oxide donation, which is intended to increase fluid outflow through the trabecular meshwork and Schlemm’s canal, with the action of bimatoprost, which increases uveoscleral outflow.
Kowa is seeking approval based on results from the pivotal Phase III Mont Blanc and Denali trials.
Both studies evaluated K-911 0.1% against latanoprost 0.005%, an established prostaglandin analogue, in patients with OAG or OHT.
Kowa said maintaining effective IOP control remains an important goal in managing these conditions because treatment requirements can change as patients’ disease progresses.
Joe Barna, president and chief executive officer of Kowa Pharmaceuticals America, said the FDA’s acceptance of the application represents an important milestone in the company’s efforts to provide another treatment option for people with OAG or OHT.
“We are proud to bring Kowa’s decades of global ophthalmology experience to the US eye care community,” Barna said.
He added that the company looks forward to working with the FDA throughout the review process.
Kowa expands rights to K-911
Kowa’s involvement with K-911 follows agreements with Nicox, the company that discovered and developed the drug candidate and led its Phase III clinical programme.
In February 2024, Kowa Company and Nicox signed an exclusive licensing agreement covering the development, manufacturing and commercialisation of K-911 in Japan.
The companies expanded their partnership in July 2025 through an additional agreement that granted Kowa rights to develop and commercialise the product in the US and other territories.
Under the current arrangement, Nicox will continue to support K-911’s development, while Kowa will lead regulatory and commercial activities in the US.
If approved, K-911 would add another option for lowering IOP in patients with OAG or OHT.
The FDA’s review will determine whether the investigational treatment can proceed to the US market.
Be the first to leave a comment