Clearside Biomedical, Inc. announced that the Therapeutic Goods Administration (TGA) of Australia has formally accepted Arctic Vision’s new drug application (NDA) for suprachoroidal use of Arcatus® (ARVN001) for the treatment of Uveitic Macular Edema. Arctic Vision is a specialty ophthalmology company based in China that has the exclusive license for the commercialization and development of XIPERE®, which they refer to as Arcatus, in Greater China, South Korea, Australia, New Zealand, India and the ASEAN Countries. 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. Macular edema is the leading cause of vision loss and blindness in uveitis patients and can occur from uveitis affecting any anatomic location - anterior, intermediate, posterior or pan. The uveitis market is expected to grow by 2024 to nearly $550 million in the United States and over $1 billion globally.

XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use, formerly known as CLS-TA, is a proprietary suspension of the corticosteroid triamcinolone acetonide for administration to the suprachoroidal space for the treatment of macular edema associated with uveitis. Bausch + Lomb, a leading global eye health company dedicated to helping people see better to live better, has the exclusive license for the commercialization and development of XIPERE in the United States and Canada. Arctic Vision, a specialty ophthalmology company based in China, has the exclusive license for the commercialization and development of XIPERE, which they refer to as Arcatus®, in Greater China, South Korea, Australia, New Zealand, India and the ASEAN Countries.

XIPERE was approved by the U.S. Food and Drug Administration in October 2021 and is commercially available in the U.S. XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use is a corticosteroid indicated for the treatment of macular edema associated with uveitis.