Kowa Submits FDA NDA for Nicox’s NCX 470 in Open-Angle Glaucoma and Ocular Hypertension

Nicox’s U.S. commercialization partner, Kowa Company, Ltd., has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for NCX 470 (bimatoprost grenod, also known as K-911) for the reduction of intraocular pressure (IOP) in adults with open-angle glaucoma or ocular hypertension. The submission marks the first regulatory filing for the investigational therapy and triggers a €3 million milestone payment to Nicox, with an additional milestone payable upon FDA approval.

Under the current review timeline, the FDA is expected to complete a standard 12-month review, potentially leading to approval in mid-2027.

Nitric Oxide-Donating Prostaglandin Analog Targets Elevated Intraocular Pressure

NCX 470 is a novel nitric oxide-donating bimatoprost ophthalmic solution that combines the IOP-lowering effect of the prostaglandin analog bimatoprost with nitric oxide-mediated relaxation of the trabecular meshwork. This dual mechanism is intended to enhance aqueous humor outflow through complementary pathways, providing greater pressure reduction than prostaglandin therapy alone.

Lowering IOP remains the only proven strategy to delay progression of glaucoma, a leading cause of irreversible blindness worldwide. Many patients require sustained pressure reduction beyond what currently available therapies achieve, highlighting the need for additional treatment options.

Phase 3 Mont Blanc and Denali Trials Supported Regulatory Filing

The NDA is based on data from the Mont Blanc (NCT04445519) and Denali (NCT04630808) Phase 3 clinical trials, which together fulfilled regulatory requirements for efficacy and safety in support of submissions in both the United States and China.

Across the pivotal studies, NCX 470 demonstrated clinically meaningful reductions in intraocular pressure while maintaining a favorable tolerability profile. The results provided the evidence package required for regulatory submission and support the therapy’s potential role as a new treatment option for patients with open-angle glaucoma or ocular hypertension.

Global Development Strategy Advances Across Major Markets

Nicox’s Chief Scientific Officer, Doug Hubatsch, said the NDA submission represents a major milestone for the company’s lead clinical asset and reflects the strength of the Phase 3 clinical evidence generated through the Mont Blanc and Denali studies. He noted that Nicox will continue working closely with Kowa and the FDA throughout the regulatory review process.

Kowa’s Junichi Kawagoe highlighted the complementary roles of the two companies, with Nicox contributing scientific and development expertise while Kowa provides regulatory and commercial capabilities. He added that the companies are preparing for a U.S. commercial launch shortly after a potential FDA approval.

Commercialization Plans Extend Beyond the United States

Under Nicox’s global licensing strategy, Kowa holds exclusive development and commercialization rights for the United States, Japan, and all territories outside China, South Korea, and Southeast Asia. Phase 3 clinical development in Japan began in summer 2025.

Ocumension Therapeutics holds exclusive rights for China, South Korea, and Southeast Asia, where regulatory submission activities are expected to follow the U.S. NDA. If approved, NCX 470 could establish a recurring royalty and milestone revenue stream for Nicox, while Kowa and Ocumension remain responsible for all regulatory and commercialization expenses within their licensed territories.

Reference

Nicox’s NCX 470 New Drug Application Submitted in the United States by Kowa, with Associated €3 million Milestone Payment