Arctic Vision Executes Collaboration Agreement with Santen for ARVN001 for the Treatment of Uveitic Macular Edema

Clearside Biomedical announced that its Asia-Pacific partner, Arctic Vision, has signed a new commercial collaboration agreement with Santen Pharmaceutical for ARVN001, branded in the United States 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.

Financial terms of the agreement were not disclosed. 

“This commercialization agreement provides additional strategic validation of our suprachoroidal delivery platform by another global pharmaceutical company,” George Lasezkay, PharmD, JD, president and CEO of Clearside, said in a company news release. “Our innovative drug delivery platform is now being used in commercial products and promising clinical development programs by Santen, Bausch + Lomb, AbbVie, Regenxbio, Aura Biosciences, and BioCryst Pharmaceuticals.”

“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," Dr. Lasezkay said. "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 US-based retinal specialists indicated that the suprachoroidal injection technique was easy to learn and resulted in favorable patient outcomes consistent with clinical trial data."

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. Arctic Vision is developing ARVN001 for other ocular retinal diseases including diabetic macular edema.