Arctic Vision files New Drug Application in China for candidate to treat uveitic macular edema

(image credit: AdobeStock/railwayfx)

Arctic Vision’s New Drug Application (NDA) for ARCATUS for the treatment of uveitic macular edema (UME) has been formally accepted for review by the Center for Drug Evaluation of China National Medical Products Administration. Positive topline results from Arctic Vision’s Phase 3 UME clinical trial in China support this NDA submission.¹

ARCATUS is known as XIPERE in the US. It has already been approved by the Food and Drug Administration in the United States, Therapeutic Goods Administration in Australia, and the Health Sciences Authority in Singapore.¹

George Lasezkay, PharmD, JD, President and Chief Executive Officer of Clearside, commented on this milestone in the company’s press release¹, saying, “Our partner, Arctic Vision, continues to make excellent progress in advancing our product in the Asia-Pacific region. The Chinese UME market is large, with several million uveitis patients. As the first SCS injection therapy, our product utilizes an innovative delivery platform that enables the rapid and adequate dispersion of medicine to the back of the eye, offering the potential for the medicine to act longer and minimize harm to the surrounding healthy parts of the eye.”

Arctic Vision is a China-based ophthalmic biotech company that has the exclusive license for the commercialization and development of triamcinolone acetonide injectable suspension (XIPERE) for suprachoroidal use, which they refer to as ARCATUS or ARVN001, in Greater China, South Korea, Australia, New Zealand, India, and the ASEAN Countries. Arctic Vision has a commercial collaboration agreement with Santen Pharmaceutical Co., Ltd. to commercialize ARVN001 for the treatment of UME and certain other ophthalmic indications under development in China, excluding Taiwan, Hong Kong and Macau. In addition, Arctic Vision is developing ARVN001 for other ocular retinal diseases, including diabetic macular edema.¹

Reference:

1. Clearside Biomedical’s Asia-Pacific Partner, Arctic Vision, Announced Acceptance of its New Drug Application for ARCATUS® for Regulatory Review in China for the Treatment of Uveitic Macular Edema. Clearside Biomedical, Inc. February 20, 2025. Accessed February 25, 2025. https://www.morningstar.com/news/globe-newswire/9361467/clearside-biomedicals-asia-pacific-partner-arctic-vision-announced-acceptance-of-its-new-drug-application-for-arcatus-for-regulatory-review-in-china-for-the-treatment-of-uveitic-macular-edema