Kowa initiates phase 3 safety trial of NCX 470 in Japan

(Image Credit: AdobeStock/vetkit)

Nicox has announced its exclusive Japanese partner, Kowa, has initiated a phase 3 safety clinical trial of NCX 470 in Japan for the treatment of ocular hypertension. This triggers approximately a $2,308,650 (€2 million) milestone payment to Nicox.¹

Nicox and Kowa entered into an agreement in February 2024, in which Kowa was granted exclusive Japanese rights to develop and commercialize NCX 470. Under the terms of the agreement, Kowa made a non-refundable upfront payment of roughly $3.4 million (€3 million) to Nicox, with a further potential of roughly $11.5 million (€10 million) in development and regulatory milestones, roughly $20.2 million (€17.5 million) in sales milestones, and tiered royalties from 7% to 12% on net sales. Kowa is responsible for all development, regulatory, and commercialization costs for NCX 470 in Japan.²

Recently, Kowa and Nicox entered into an agreement granting Kowa exclusive rights to develop and commercialize NCX 470 in the US and all other territories of the world. This deal excluded China, Korea, and Southeast Asia, where it is currently licensed to Ocumension Therapeutics.³

Doug Hubatsch, EVP Scientific Officer of Nicox, commented on the trial in a press release from the company, saying, “Thanks to our continuing collaborative efforts after Kowa received approval to initiate this trial, we are very pleased to announce that the first patient has been enrolled.”

According to the company, only 1 phase 3 confirmatory clinical trial in Japanese patients, which will start shortly, plus the safety trial, is required for submission for marketing approval of NCX 470 in Japan.

The safety trial is a long-term study of NCX 470 (bimatoprost grenod) in patients with primary open-angle glaucoma (POAG), exfoliative glaucoma, pigmentary glaucoma, or ocular hypertension. The primary outcome is changes from baseline in intraocular pressure after 2 weeks. The trial aims to include 120 patients.⁴

The phase 3 confirmatory trial is expected to “start shortly” and is expected to enroll 500 patients with POAG. The primary outcome is changes from baseline in intraocular pressure at weeks 2, 4, and 6.⁵

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 2 different pathways in patients with open-angle glaucoma or ocular hypertension. NCX 470 incorporates Nicox’s proprietary NO-donating research platform and bimatoprost in a single molecule.⁶

References:

1. Nicox’s Partner Kowa Initiates NCX 470 Phase 3 Clinical Trial in Japan. Published August 5, 2025. Accessed August 5, 2025. https://www.globenewswire.com/news-release/2025/08/05/3127028/0/en/Nicox-s-Partner-Kowa-Initiates-NCX-470-Phase-3-Clinical-Trial-in-Japan.html

2. Nicox and Kowa Enter into Agreement for NCX 470 Development and Commercialization in Japan. Published February 8, 2024. Accessed August 5, 2025. https://www.nicox.com/wp-content/uploads/EN_Kowa-Japan-NCX470-Licensing-PR_20240208_F.pdf

3. Harp MD. Nicox and Kowa sign agreement for exclusive rights to glaucoma treatment NCX 470. Published July 20, 2025. Accessed August 5, 2025. https://www.ophthalmologytimes.com/view/nicox-and-kowa-sign-agreement-for-exclusive-rights-to-glaucoma-treatment-ncx-470

4. Japan Registry of Clinical Trials. jRCT2051250049. Accessed August 5, 2025. https://jrct.mhlw.go.jp/en-latest-detail/jRCT2051250049

5. Japan Registry of Clinical Trials. jRCT2051250050. Accessed August 5, 2025. https://jrct.mhlw.go.jp/en-latest-detail/jRCT2051250050

6. Portfolio and disease areas. Nicox SA. Accessed July 17, 2025. https://www.nicox.com/pipeline-markets-and-science/#product-ncx-470