The U.S. Food and Drug Administration accepted Kowa Pharmaceuticals America’s New Drug Application for K-911, also known as NCX 470 or bimatoprost grenod, an investigational once-daily nitric oxide-donating bimatoprost eye drop for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The FDA set April 30, 2027, as the PDUFA target action date. K-911 is designed to lower pressure through two 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 the pivotal Phase 3 Mont Blanc and Denali trials, which compared K-911 0.1% with latanoprost 0.005% and showed intraocular-pressure reductions of up to 10mmHg with a favorable safety profile. Kowa anticipates a U.S. launch in the second half of 2027, subject to approval. Nicox discovered and developed K-911 and led the Phase 3 trials, while Kowa is responsible for U.S. regulatory and commercialization activities. A separate China NDA was submitted in August 2026 through Nicox’s partner Ocumension Therapeutics, and a Phase 3 program in Japan remains ongoing.