The US Food and Drug Administration (FDA) has accepted Kowa Pharmaceuticals America’s new drug application (NDA) for K-911 (bimatoprost grenod), a once-daily eye drop for lowering intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). The FDA has assigned a Prescription Drug User Fee Act target action date of April 30, 2027.

K-911, previously known as NCX 470, is a nitric oxide–donating bimatoprost formulated as a topical ophthalmic solution. The drug is designed to lower IOP through 2 mechanisms: nitric oxide is intended to increase conventional aqueous humor outflow through the trabecular meshwork and Schlemm canal, while bimatoprost increases uveoscleral outflow.

The NDA is supported by the phase 3 Mont Blanc and Denali trials, which compared K-911 0.1% with latanoprost 0.005% in patients with OAG or OHT. According to Kowa, the studies demonstrated clinically meaningful reductions in IOP with a favorable safety profile.

The drug was developed by Nicox and is licensed to Kowa for Japan and most global markets, including the United States. Ocumension Therapeutics holds commercialization rights in China, South Korea, and Southeast Asia.

If the drug is approved, Kowa said it anticipates a US launch in the second half of 2027. GP