New drug application accepted by Australia’s Therapeutic Goods Administration for Arcatus (ARVN001) in the treatment of uveitic macular edema

The drug, known as XIPERE in the US, is used to treat uvietic macular edema and goes by the name Arcatus when licensed by Clearside Biomedical’s partner in China, Arctic Vision. Image credit: ©fizkes – stock.adobe.com

Australia’s Therapeutic Goods Administration (TGA) has formally accepted Arctic Vision’s (Clearside Biomedical's partner) new drug application (NDA) for suprachoroidal use of Arcatus (ARVN001) for the treatment of uveitic macular edema. 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.¹

In the press release, George Lasezkay, PharmD, JD, President and Chief Executive Officer of Clearside shared the company’s progress with the drug and the next steps toward its broader use around the globe. “Acceptance of the NDA in Australia is additional validation of suprachoroidal administration as an innovative, recognized form of ophthalmic drug delivery and another step towards the global commercialization of XIPERE. With approval in the US, regulatory review ongoing in Australia, and plans to gradually submit applications in more countries in its territories, our partner Arctic Vision continues to expand access for patients to the only product approved for the treatment of macular edema associated with uveitis.”¹

About Uveitis and Macular Edema

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.

About XIPERE (triamcinolone acetonide injectable suspension) for suprachoroidal use

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 US. Food and Drug Administration in October 2021 and is commercially available in the US.

Reference:

1. Clearside Biomedical Asia-Pacific Partner Arctic Vision Announces the Acceptance in Australia of its New Drug Application for Suprachoroidal Use of Arcatus® for the Treatment of Uveitic Macular Edema. Clearside Biomedical, Inc. July 10, 2023. Accessed July 11, 2023. https://www.globenewswire.com/news-release/2023/07/10/2701644/0/en/Clearside-Biomedical-Asia-Pacific-Partner-Arctic-Vision-Announces-the-Acceptance-in-Australia-of-its-New-Drug-Application-for-Suprachoroidal-Use-of-Arcatus-for-the-Treatment-of-Uve.html