Nicox and Kowa enter commercialisation agreement for NCX 470 glaucoma eye drop

Ocumension Therapeutics holds an established licensing agreement for NCX 470 in China, Korea and Southeast Asia. Image credit: ©Asma – stock.adobe.com

Nicox and Kowa have entered into an agreement regarding NCX 470, Nicox’s nitric oxide (NO)-donating bimatoprost eye drop, for the lowering of intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.

According to the agreement, Kowa receives exclusive rights to develop and commercialise NCX 470 in all territories of the world excluding Japan, China, Korea and Southeast Asia.

Kowa already has a license to NCX 470 for Japan, where it is preparing to enter a phase 3 clinical trial. NCX 470 is currently licensed to Ocumension Therapeutics for China, Korea, and Southeast Asia.

NCX 470 is a novel nitric oxide (NO)–donating bimatoprost eye drop that leverages the IOP-lowering effects of NO and prostaglandin analogs (PGAs) and is designed to release bimatoprost and NO into the eye to lower IOP by two different pathways in patients with open-angle glaucoma or ocular hypertension.

Under the terms of the agreement, Nicox will receive an upfront payment of approximately €7.5 million ($8.6 million, as noted by the company) on signing. Additional near-term milestone payments are due on positive topline results from the Denali clinical trial, expected mid-August to mid-September 2025. A milestone payment is also due on submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA), which is currently expected in the second half of 2026.

Nicox notes that the total potential development and sales milestones payments will be approximately €127 million ($147 million) or approximately €191.5 million ($222 million), depending on the outcome of the Denali clinical trial.

Gavin Spencer, CEO of Nicox, commented on the partnership in a press release from the company.

"This new agreement with our existing partner, Kowa, is a major endorsement of NCX 470’s potential in glaucoma and marks a major step forward in strengthening Nicox’s financial position. With NCX 470 now globally licensed, we are focused on delivering the Denali Phase 3 results, which we anticipate releasing mid-August to mid-September,” said Spencer. “The revenue stream we expect from NCX 470 gives us the flexibility to pursue future growth opportunities, leveraging our expert U.S. ophthalmology development team.”

Nicox recently announced that the last patient has completed its Denali phase 3 trial, which is evaluating the efficacy and safety of NCX 470 in patients with open-angle glaucoma or ocular hypertension.² The company noted that all 696 patients in the trial have completed their treatment and follow-up visits.

NCX 470 incorporates Nicox’s proprietary NO-donating research platform and bimatoprost in a single molecule.³ The Denali trial, together with the already completed Mont Blanc trial, was designed to fulfill the clinical regulatory requirements to support NDA submissions of NCX 470 in the US and China.

Topline results from the Denali trial are expected mid-August to mid-September 2025, according to the company. Additionally, NCX 470 phase 3 clinical efficacy and long-term safety trials in Japan are expected to begin in the second half of 2025.

References:

1. Nicox and Kowa sign key agreement worth up to €191.5 million for exclusive rights to glaucoma treatment NCX 470 in US and all unlicensed territories. Published July 17, 2025. Accessed July 17, 2025. https://www.globenewswire.com/news-release/2025/07/17/3116959/0/en/Nicox-and-Kowa-Sign-Key-Agreement-worth-up-to-191-5-million-for-Exclusive-Rights-to-Glaucoma-Treatment-NCX-470-in-U-S-and-all-Unlicensed-Territories.html
2. Harp MD. Nicox completes phase 3 Denali trial of NCX 470 in open-angle glaucoma or ocular hypertension. Published June 30, 2025. Accessed July 17, 2025. https://www.ophthalmologytimes.com/view/nicox-completes-phase-3-denali-trial-of-ncx-470-in-open-angle-glaucoma-or-ocular-hypertension
3. Portfolio and disease areas. Nicox SA. Accessed July 17, 2025. https://www.nicox.com/pipeline-markets-and-science/#product-ncx-470