Kowa Pharmaceuticals America Announces FDA Acceptance of New Drug Application for K-911, an Investigational IOP-Lowering Eye Drop for Patients with Open-Angle Glaucoma or Ocular Hypertension

Investigational K-911 is a once-daily nitric oxide-donating bimatoprost eye drop designed to lower intraocular pressure

NDA is supported by two pivotal Phase 3 trials

FDA assigns PDUFA target action date of April 30, 2027

MONTGOMERY, Ala., Aug. 27, 2026 /PRNewswire/ -- Kowa Pharmaceuticals America, Inc. (KPA), today 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 topical ophthalmic monotherapy for the reduction of 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.

"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, CPA, Chief Executive Officer and President of KPA. "We're proud to bring Kowa's decades of global ophthalmology experience to the U.S. eye care community, and we look forward to working with the FDA throughout the review process."

K-911 is an investigational, once-daily nitric oxide-donating bimatoprost monotherapy formulated as a sterile ophthalmic solution and engineered to lower IOP through two distinct aqueous humor 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 analog, in patients with OAG or OHT. 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 needs varying from patient to patient and over time.

In February 2024, Kowa Company, Ltd. and Nicox S.A. entered into an exclusive licensing agreement for the development, manufacturing and commercialization of K-911 in Japan, followed by an agreement in July 2025 granting Kowa rights to develop and commercialize K-911 in the United States 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 U.S. regulatory and commercialization activities. The FDA's acceptance of the K-911 NDA for filing marks the next regulatory milestone for K-911 in the U.S. as the application proceeds through FDA review. Following confirmation of a PDUFA target action date of April 30, 2027, Kowa anticipates a U.S. commercial launch in the second half of 2027, subject to approval.

About Glaucoma and Ocular Hypertension

Glaucoma is a progressive eye disease that can cause irreversible optic nerve damage leading to vision loss and potential blindness.^1,2 More than 4.2 million adults in the U.S. live with glaucoma, with open-angle glaucoma representing the most common form of the disease.³ Lowering intraocular pressure is the only proven approach to slowing glaucoma disease progression.^1,2

Ocular hypertension is characterized by elevated intraocular pressure without detectable optic nerve damage or vision loss.⁴ Although ocular hypertension may not cause symptoms, elevated IOP is an important risk factor for the development of glaucoma.⁴ An estimated 3-6 million people in the U.S. live with ocular hypertension.⁴

About K-911

K-911 (bimatoprost grenod), also known as NCX 470, is an investigational, once-daily nitric oxide-donating bimatoprost eye drop being developed for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The NDA is supported by the Phase 3 Mont Blanc and Denali trials. K-911 is an investigational product and has not yet been approved by the FDA. Kowa holds exclusive rights to develop and commercialize K-911 in the U.S.

About Kowa Pharmaceuticals America, Inc.

Kowa Pharmaceuticals America, Inc. (KPA) is a Montgomery, Alabama-based specialty pharmaceutical company with 18 years of experience developing and commercializing pharmaceuticals for the U.S. market. As part of Kowa Company, Ltd. (KCL), KPA is building on Kowa's decades of global ophthalmology expertise as it expands its presence in the U.S. eye care community. For more information, please visit www.kowapharma.com.

References

1. Cleveland Clinic. (2024, November 12). Glaucoma: What it is, symptoms, causes, types & treatment. Cleveland Clinic. https://my.clevelandclinic.org/health/diseases/4212-glaucoma
2. National Eye Institute. (2025, November 26). Glaucoma. U.S. Department of Health and Human Services. https://www.nei.nih.gov/eye-health-information/eye-conditions-and-diseases/glaucoma 
3. Seminara, L. (2025, February 1). Updated prevalence of glaucoma in the United States. EyeNet Magazine. American Academy of Ophthalmology. https://www.aao.org/eyenet/article/updated-prevalence-glaucoma-united-states 
4. Cleveland Clinic. (2022, December 19). Ocular hypertension: Causes, symptoms & treatment. Cleveland Clinic. https://my.clevelandclinic.org/health/diseases/24621-ocular-hypertension 

Christian Vaughn, [email protected] 

SOURCE Kowa Pharmaceuticals America, Inc.