Kowa Company has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for NCX 470 (bimatoprost grenod), an investigational nitric oxide-donating bimatoprost eye drop for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

The submission, announced by Nicox SA, is supported by results from the phase 3 Mont Blanc and Denali clinical trials, which were designed to satisfy US regulatory requirements for efficacy and safety. According to the companies, the studies demonstrated clinically meaningful reductions in IOP with a favorable safety profile.

NCX 470 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.

The NDA is expected to undergo a 12-month FDA review. Junichi Kawagoe, director and senior managing executive officer of Kowa, said the companies are preparing for a potential US commercial launch in the second half of 2027.

The submission triggers a $3.4 million milestone payment from Kowa to Nicox, with an additional milestone payment due if the therapy receives FDA approval. GP