Nicox: Kowa Files FDA Approval Application for NCX 470, €3M Milestone Achieved
On Wednesday, Kowa submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for NCX 470, Nicox's leading eye drop aimed at reducing intraocular pressure in patients with glaucoma or ocular hypertension. Nicox will receive a milestone payment of 3 million euros, followed by a second installment upon approval.
Innovative Nitric Oxide Eye Drop Under Regulatory Review
NCX 470 (bimatoprost grenod) is an innovative eye drop releasing nitric oxide, designed to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The application filed by Kowa, Nicox's exclusive partner in the United States, is based on the positive results from two Phase 3 clinical trials named Mont Blanc and Denali.
These trials demonstrated that NCX 470 significantly reduced intraocular pressure with a favorable safety profile.
Approval Expected by Mid-2027 with Commercial Launch Before Year-End
The FDA is expected to review the application over a standard 12-month period, leading to an anticipated approval by mid-2027. A commercial launch in the United States is planned before the end of 2027.
Kowa will bear all regulatory and commercial costs related to the development and marketing of NCX 470 in this territory.
An Exclusive Licensing Network Covering Key Markets
NCX 470 is exclusively licensed to Ocumension Therapeutics for China, South Korea, and Southeast Asia, while Kowa holds the rights in Japan and the rest of the world. Phase 3 clinical trials began in Japan in the summer of 2025, and Ocumension is preparing an authorization request in China following this U.S. filing.
In exchange for these exclusive licenses, Nicox will receive regulatory and commercial milestones as well as royalties on global sales.
