Clearside Biomedical’s Partner Arctic Vision Signs Commercial Collaboration with Santen for ARVN001 in China

Clearside Biomedical has announced that Arctic Vision, its Asia-Pacific partner, has signed a commercial collaboration agreement with Santen Pharmaceutical Co. for ARVN001 (known in the United States as XIPERE) to treat uveitic macular edema (UME) and additional ophthalmic indications in development. This agreement grants Santen the rights to commercialize ARVN001 in China, excluding Taiwan, Hong Kong, and Macau.

About ARVN001 (XIPERE) and Suprachoroidal Delivery Technology

ARVN001 is a triamcinolone acetonide injectable suspension specifically formulated for suprachoroidal use, designed to treat UME by targeting drug delivery to the back of the eye. Developed by Clearside Biomedical, XIPERE is currently marketed in the United States by Bausch + Lomb.

George Lasezkay, PharmD, JD, President and CEO of Clearside, emphasized the significance of this collaboration:

“This commercialization agreement provides additional strategic validation of our suprachoroidal delivery platform by another global pharmaceutical company. 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.”

Strategic Expansion for ARVN001 in the Asia-Pacific Region

Arctic Vision has made considerable advancements in developing ARVN001 across the Asia-Pacific region. With a successful Phase 3 trial in China and regulatory reviews in Australia and Singapore, Arctic Vision is working toward approval and commercialization in multiple markets.

“Arctic Vision has made excellent progress advancing our product in the Asia-Pacific region, with regulatory review ongoing in Australia and Singapore and a pending submission for approval in China,” Dr. Lasezkay noted. “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.”

Benefits of SCS Microinjector for Suprachoroidal Delivery

This collaboration also enables training and adoption of Clearside’s proprietary SCS Microinjector, supporting broader implementation in international markets. Recent data from a U.S. survey of retinal specialists indicated that the suprachoroidal injection technique is user-friendly, with outcomes aligned with clinical trial data, reflecting a positive reception among eye care professionals.

Arctic Vision’s Commitment to Expanding ARVN001 Applications

Headquartered in China, Arctic Vision holds exclusive commercialization and development rights for XIPERE (ARVN001) across Greater China, South Korea, Australia, New Zealand, India, and the ASEAN region. Following its positive Phase 3 results in China, Arctic Vision is currently pursuing regulatory approval for ARVN001 in Australia and Singapore for UME treatment. Additionally, Arctic Vision is exploring further indications for ARVN001, including diabetic macular edema and other retinal conditions.

This partnership between Arctic Vision and Santen represents a critical milestone in advancing suprachoroidal delivery technology, bringing innovative treatment options to UME patients across the Asia-Pacific region.