Santen and Arctic Vision execute a commercial collaboration agreement for ARVN001, a suprachoroidal space injection therapy for the treatment of uveitic macular edema

November 7, 2024 - Osaka, Japan, - Santen Pharmaceutical Co., Ltd. (head office: Osaka, Japan; hereinafter Santen), a specialized company dedicated to eye health, and Arctic Vision (Hong Kong) Limited (head office: Shanghai, China; hereinafter Arctic Vision), a China-based biotech company focused on innovative ophthalmic therapies, today announced the signing of a commercial collaboration agreement for ARVN001, Arctic Vision’s triamcinolone acetonide suprachoroidal injectable suspension and its injector with the patented SCS Microinjector^® (SCS = suprachoroidal space) technology for the treatment of uveitic macular edema (UME) and certain other ophthalmic indications under development, for China excluding Taiwan, Hong Kong and Macau (hereinafter Territory). Under the terms and conditions of this agreement, Arctic Vision grants exclusive commercialization rights in the Territory to Santen.

Uveitis is the inflammation of the uveal tract, the vascular layer between the sclera (the outer protective layer of the eye) and the retina, which can lead to significant visual impairment.¹ Uveal tract consists posteriorly of the choroid, in the middle part of the ciliary body and anteriorly of the iris.¹ Macular edema is a common complication in patients with uveitis, which is characterized by a build-up of fluid in the macula, the area of the retina responsible for sharp, straight-ahead vision.²

ARVN001 is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the suprachoroidal space. ARVN001 was licensed to Arctic Vision for the Asia-Pacific region by Clearside Biomedical, Inc. and has already received FDA approval in the U.S. for the treatment of UME under the brand name XIPERE^®, making it the first and currently the only approved suprachoroidal therapy for UME. It is now being investigated by Arctic Vision for other ocular retinal diseases. In July 2024, Arctic Vision announced positive topline results of ARVN001’s China Phase III clinical trial. The Clearside patented SCS Microinjector^® technology is designed to deliver the drug to the suprachoroidal space located between the choroid and the sclera. Suprachoroidal injection enables the rapid and adequate dispersion of the drug to the back of the eye, offering the potential for the drug to act longer and minimize harm to the surrounding healthy parts of the eye. ²

“Through this partnership with Arctic Vision, an ophthalmic biotech company that continues to pioneer new developments, we will be able to bring this potentially first reimbursable UME treatment to patients in China. This partnership has the potential to create new opportunities for Santen to address unmet needs related to the posterior segment eye diseases in China,” said Rie Nakajima, Director of the Board, Chief Operating Officer of Santen.

“ARVN001 is the first and only suprachoroidal space injection therapy for UME in China, and Arctic Vision has made great efforts moving the program from clinical trial to NDA stage.” said Dr. Eddy Wu, Founder, Chairman and Chief Executive Officer of Arctic Vision. “We are very excited to enter into this partnership with Santen on the commercialization of this cutting-edge therapy, with their strong commercial capability, we look forward to maximizing the great potential of this therapy and bringing the innovative eyecare solutions to the UME patients and professionals in China.”

Under the terms of the agreement, Arctic Vision will receive up to US $85 million in upfront, milestone payments. Santen and Arctic Vision’s strategic collaboration also heralds a synergistic partnership, where both companies will leverage their expertise and insights to strengthen their collaboration and jointly thrive in the Chinese ophthalmology market and UME patients in China.

References

1. Massa et al, Clinical Ophthalmology 2019;13: 1761–77.
2. Accorinti et al, Ocular Immunology & Inflammation 2019; 27: 169–80.

• SCS Microinjector^® is a registered trademark of Clearside Biomedical Inc.
• XIPERE^®is a registered trademark of Clearside Biomedical Inc. Full prescribing information in the U.S. is available here.

About Arctic Vision
Arctic Vision is a China-based ophthalmic biotech focusing on breakthrough therapies, with a leading portfolio covering pre-clinical stage to commercial stage products. The company’s vision is to provide innovative therapies in China, Asia and globally to address unmet clinical needs and benefit ophthalmic patients at large. Arctic Vision is supported by top-tier life sciences investors and led by an elite team of ophthalmic industry veterans with substantial regional and global experiences in R&D and commercialization of ophthalmic products..
For more information, please visit Arctic Vision’s website https://www.arcticvision.com.

About Santen
As a specialized company dedicated to eye health, Santen aspires to contribute to the realization of “Happiness with Vision” by providing products and services to patients, consumers, and medical professionals around the world. Since its establishment, and guided by its CORE PRINCIPLE, “Tenki ni sanyo suru,” Santen has been committed to helping people maintain and improve their eye health for more than 130 years. Santen is engaged in the global research and development, manufacturing, and sales and marketing of pharmaceutical products in the field of eye care, supporting the eye health of approximately 50 million people in more than 60 countries and regions worldwide. Santen’s mission is to provide essential and significant value to patients and society in the prevention, diagnosis, and treatment of eye diseases through products and services created from its expertise in the ophthalmology field and from the patient's perspective. To create a future in which as many patients as possible can lead happy and fulfilling lives, Santen is committed to doing its utmost to realize a society in which people around the world can experience “Happiness with Vision.”
For more information, please visit Santen’s website https://www.santen.com/en.

Contact
Corporate Communications
Santen Pharmaceutical Co., Ltd.
E-mail: communication@santen.com   

Corporate Communications
Arctic Vision (Hong Kong) Limited
Email: communications@arcticvision.com

This press release has been published in Japanese, Simplified Chinese and English languages and in the event of any inconsistency, the English version shall prevail.