This milestone was announced by Clearside Biomedical, Inc., Arctic Vision's partner. ARCATUS, also known as XIPERE®, utilizes a revolutionary suprachoroidal delivery platform, offering new hope to patients in China suffering from this vision-threatening condition.
Arctic Vision has completed enrollment in its Phase 3 randomized, double-blind, placebo-controlled clinical trial in China for suprachoroidal use of ARCATUS® (ARVN001) for the treatment of uveitic macular edema. Clearside Biomedical, Inc. a partner of Artic Vision announced in a press release.
Arctic Vision is a specialty ophthalmology company based in China that has the exclusive license for commercialization and development of XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use, which they refer to as ARCATUS, in Greater China, South Korea, Australia, New Zealand, India and the ASEAN Countries, according the release from Clearside Biomedical.1
XIPERE was approved by the US Food and Drug Administration in October 2021 and is commercially available in the US.1
“This achievement represents significant progress in expanding the global acceptance of our revolutionary suprachoroidal delivery platform,” said George Lasezkay, PharmD, JD, president and CEO of Clearside. “The continued development of ARCATUS by our partner, Arctic Vision, offers new hope to patients in China suffering from uveitic macular edema. As the clear leader in delivering drugs and drug candidates into the suprachoroidal space, our innovative, proprietary SCS Microinjector® provides an in-office, nonsurgical, repeatable delivery option with a reliable and robust safety profile, based on thousands of SCS injections performed to date.”
Uveitis is a set of ocular inflammatory conditions and is one of the leading causes of vision loss, affecting approximately 350,000 patients in the United States and more than one million worldwide. Approximately one-third of these patients develop uveitic macular edema, a build-up of fluid in the macula, the area of the retina responsible for sharp, straight-ahead vision.1