Clearside Biomedical Partner Arctic Vision Executes Commercial Collaboration Agreement with Santen Pharmaceutical Co., Ltd for ARVN001 Suprachoroidal Space Injection Therapy for the Treatment of Uveitic Macular Edema

Clearside Biomedical, Inc., a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS), announced that the Company’s Asia-Pacific partner, Arctic Vision, has signed a new commercial collaboration agreement with Santen Pharmaceutical Co., Ltd. for ARVN001, branded in the U.S. as XIPERE, for the treatment of uveitic macular edema (UME) and certain other ophthalmic indications under development. Under the terms and conditions of the agreement, Arctic Vision has granted the rights of ARVN001 to Santen to commercialize the product candidate in China excluding Taiwan, Hong Kong and Macau. XIPERE (triamcinolone acetonide injectable suspension) for suprachoroidal use was developed by Clearside and is currently being sold in the United States by Bausch + Lomb.

“This commercialization agreement provides additional strategic validation of our suprachoroidal delivery platform by another global pharmaceutical company,” said George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer of Clearside. “Our innovative drug delivery platform is now being used in commercial products and promising clinical development programs by Santen, Bausch + Lomb, AbbVie Inc., REGENXBIO Inc., Aura Biosciences, Inc. and BioCryst Pharmaceuticals, Inc.”

“Arctic Vision has made excellent progress advancing our product in the Asia-Pacific region with a positive Phase 3 trial, regulatory review ongoing in Australia and Singapore, and a pending submission for approval in China. Leveraging the global capabilities of Santen to commercialize ARVN001, if approved in China, is another successful step to bring this important treatment to UME patients in the Asia-Pacific region. This partnership will enable training and use of our SCS Microinjector in major international markets, which provides benefit to Clearside and all of our partners in driving the adoption of SCS delivery. Recently published data from a survey of U.S.-based retinal specialists indicated that the suprachoroidal injection technique was easy to learn and resulted in favorable patient outcomes consistent with clinical trial data,” Dr. Lasezkay concluded.

Arctic Vision is a specialty ophthalmology company based in China that has the exclusive license for the commercialization and development of XIPERE, which they refer to as ARVN001, in Greater China, South Korea, Australia, New Zealand, India and the ASEAN Countries. In July 2024, Arctic Vision announced positive topline results from its Phase 3 clinical trial in China in UME. They also have New Drug Applications for ARVN001 under review in Australia and Singapore for the treatment of UME. In addition, Arctic Vision is developing ARVN001 for other ocular retinal diseases including diabetic macular edema.