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

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.”

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