Clearside Biomedical's Asia-Pacific Partner Arctic Vision Secures Approval for Suprachoroidal Treatment in Australia and Singapore

Clearside Biomedical’s Asia-Pacific Partner, Arctic Vision has received regulatory approval for ARCATUS (triamcinolone acetonide 4 mg/0.1 mL injection suspension vial kit) from the Therapeutic Goods Administration (TGA) of Australia and the Health Sciences Authority (HSA) of Singapore. The approval marks a significant step forward in the treatment of uveitic macular edema (UME) in the Asia-Pacific region.

ARCATUS: A Key Advancement in UME Treatment

Known as XIPERE in the United States, ARCATUS® is a therapeutic innovation developed by Clearside Biomedical. It utilizes Clearside’s proprietary Suprachoroidal Space (SCS) delivery platform to provide targeted, compartmentalized drug delivery to the back of the eye.

XIPERE Approval History

       • Approved by the U.S. Food and Drug Administration (FDA) in October 2021.

       • Commercially available in the U.S., with exclusive licensing to Bausch + Lomb for development and distribution in the U.S. and Canada.

Arctic Vision’s Licensing Scope

Arctic Vision, a China-based ophthalmic biotech, holds exclusive rights for the commercialization and development of ARCATUS® in:

       • Greater China

       • South Korea

       • Australia and New Zealand

       • India and ASEAN Countries

Leadership Perspectives

George Lasezkay, PharmD, JD, President and CEO of Clearside Biomedical, praised Arctic Vision’s progress:

“We congratulate our partner, Arctic Vision, for the outstanding progress advancing our product in the Asia-Pacific region. These global regulatory approvals confirm that our innovative SCS delivery platform enables the treatment of patients with sight-threatening eye diseases. We expect that retinal specialists across the world will use this in-office, repeatable, non-surgical procedure for the targeted and compartmentalized delivery of a wide variety of potential therapies.”

Arctic Vision’s Development Milestones

       • Phase 3 Success in China: In July 2024, Arctic Vision announced positive topline results from its Phase 3 UME clinical trial in China.

       • Expanding Indications: Arctic Vision is also developing ARVN001 for additional retinal diseases, including diabetic macular edema (DME).

Clearside’s SCS Microinjector

Clearside’s patented SCS Microinjector delivers drugs directly into the suprachoroidal space, offering several advantages:

       • Targeted Drug Delivery: Improves efficacy by concentrating medication in affected areas while protecting non-diseased cells.

       • Flexible Application: Compatible with a wide range of established and experimental drug formulations.

       • Minimally Invasive: Provides a repeatable, in-office, non-surgical treatment option for retinal diseases.

Conclusion

The approvals of ARCATUS in Australia and Singapore highlight the global potential of Clearside’s SCS delivery platform and Arctic Vision’s commitment to advancing ophthalmic care in the Asia-Pacific region. With these milestones, ARCATUS® is set to transform the treatment landscape for patients with uveitic macular edema and other sight-threatening retinal conditions.