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Arctic Vision Announces TGA Acceptance of New Drug Application for Arcatus® (ARVN001) to Treat Uveitic Macular Edema (UME) in Australia

Shanghai, China - June 30, 2023 - Arctic Vision, a China-based biotech company focused on innovative ophthalmic therapies, announced today that the Therapeutic Goods Administration (TGA) of Australia has formally accepted its new drug application (NDA) for Arcatus® (Arctic Vision’s project code ARVN001) for the treatment of Uveitic Macular Edema (UME). ARVN001 is a triamcinolone acetonide suprachoroidal injectable suspension, utilizing the globally pioneering Suprachoroidal Space Microinjection (SCS Microinjection) therapy. This innovative therapy, known as XIPERE™ in the U.S., represents the first and currently only approved therapy to treat UME globally.

The suprachoroidal space (SCS) is a space between the sclera and the choroid. Suprachoroidal injection 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. SCS has been proven as a promising drug delivery technology. 

UME is one of the most common and severe complications of uveitis, and it is the leading cause of permanent visual impairment associated with the condition. It not only affects the vision and quality of life of patients but also places a heavy burden on their families and society. The current primary treatment option for UME involves the local administration of corticosteroids. However, this approach often leads to adverse events such as cataracts, increased intraocular pressure, and glaucoma, causing distress and burden to patients. As the first SCS injection therapy, ARCATUS®(ARVN001) utilizes an innovative delivery platform to administer triamcinolone acetonide, enabling potent anti-inflammatory effects of glucocorticoids. It also enhances the safety of the treatment, offering a promising new approach for a broader range of ophthalmic patients.

Dr. Eddy Wu, CEO and Founder of Arctic Vision, stated, " The acceptance of the NDA filing of ARVN001 in Australia marks a significant milestone for Arctic Vision in the global commercialization of ARCATUS® (ARVN001), bringing a revolutionary solution to Uveitic Macular Edema patients and addressing their critical clinical needs. Moving forward, we have plans to gradually submit applications in more countries and regions, with the aim of bringing this innovative therapy to more UME patients."

Arctic Vision has always been committed to delivering breakthrough cutting-edge technologies and consumer-centric innovations, empowering patients and consumers in China, Asia, and around the globe to effectively overcome eye health challenges, enabling them to see more clearly and enjoy a better quality of life.

About 锋脉® / Arcatus (ARVN001)

ARVN001 (known in China as 锋脉 or Arcatus) is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the suprachoroidal space. It has been approved in the U.S. for the treatment of macular edema associated with uveitis (UME) and is now being investigated for diabetic macular edema (DME) and other ocular fundus diseases. The patented SCS Microinjector technology is designed to deliver drug to the suprachoroidal space located between the choroid and the outer protective layer of the eye, known as the sclera. Suprachoroidal injection 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.


In March 2020, Arctic Vision acquired the exclusive license for the development and commercialization of XIPERE from U.S.-based ophthalmology player Clearside Biomedical, Inc. (NASDAQ: CLSD) in Greater China and South Korea, later expanding the license territory to include ASEAN countries and India, and subsequently Australia and New Zealand, in August and September 2021 respectively. ARVN001 is Arctic Vision’s project code for XIPERE.


In September 2021, CFDA has approved the second indication of ARVN001 for the treatment of diabetic macular edema (DME) to proceed to Phase I study. In November 2021, the first set of patients have been dosed in the Phase III study of ARVN001 for the treatment of macular edema associated with uveitis (UME) in China.


About Arctic Vision

Arctic Vision is a China-based ophthalmic biotech focusing on breakthrough therapies, with a leading portfolio covering pre-clinical stage to commercial stage products. Our vision is to provide innovative therapies in China, Asia and globally to address unmet clinical needs and benefit ophthalmic patients at large. Arctic Vision is supported by top-tier life sciences investors and led by an elite team of ophthalmic industry veterans with substantial regional and global experiences in R&D and commercialization of ophthalmic products. 


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