The U.S. Food and Drug Administration has accepted Kowa Pharmaceuticals America’s New Drug Application for K-911 (bimatoprost grenod, also known as NCX 470), an investigational once-daily eye drop for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
The regulator set a Prescription Drug User Fee Act target action date of April 30, 2027, with a potential U.S. commercial launch in the second half of 2027 if the drug receives approval. Kowa, which holds U.S. rights under a 2025 licensing agreement with Nicox, will oversee regulatory and commercialization activities for the product.
K-911 is designed to lower intraocular pressure through two aqueous humor outflow pathways, positioning it as a potential alternative to existing treatments such as latanoprost 0.005%. Nicox led the Phase 3 clinical trials, Mont Blanc and Denali, while Kowa manages development and commercialization in licensed territories outside Japan, where Nicox retains rights under a separate 2024 agreement with Kowa Company.
The FDA’s acceptance of the NDA follows the submission of clinical data demonstrating the drug’s efficacy and safety profile. Glaucoma affects more than 4.2 million adults in the U.S., with an additional 3 to 6 million living with ocular hypertension, underscoring the market opportunity for new therapeutic options.
