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Arctic Vision Completes Enrollment in Phase III Clinical Trial of Suprachoroidal Space Injection Therapy ARVN001 for Uveitic Macular Edema Patients in China

-         First-in-class SCS Microinjection Therapy

-         First Clinical Trial in China for Uveitic Macular Edema and Potentially First Approved Drug in China

-         FDA Approved, the First and Only Approved Treatment Globally for Uveitic Macular Edema


Shanghai, China, September 28, 2023 – Arctic Vision, a China-based biotech company focused on innovative ophthalmic therapies, today announced the completion of patient enrollment in its Phase III clinical trial of 锋脉®/ARCATUS® (ARVN001), a triamcinolone acetonide suprachoroidal injectable suspension, for the treatment of Uveitic Macular Edema (UME) in China. This remarkable milestone is set to transform innovative therapy and bring hope to UME patients in China. It has already received FDA approval in the U.S. for the treatment of UME under the brand name XIPERE™, making it the first and currently the only approved therapy for Uveitic Macular Edema worldwide. Furthermore, the drug's new drug application in Australia was officially accepted in July 2023.


The Phase III trial in China is a double-blind, randomized, placebo-controlled study designed to assess the efficacy and safety of 锋脉®/ARCATUS® (ARVN001) in UME patients. This innovative medication employs the patented Suprachoroidal Space Microinjection (SCS Microinjection®) technology, which enables 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 recent years, SCS has been proven as a promising drug delivery technology.


Dr. Qing Liu, Co-founder and Chief Medical Officer of Arctic Vision, stated, "The successful enrollment completion of the Phase III clinical trial for 锋脉®/ARCATUS® (ARVN001) is of great significance to UME patients and the entire field of ophthalmology. We remain committed to advancing the R&D development of ARVN001 in China to address the unmet need for Uveitic Macular Edema treatments. Additionally, we anticipate that ARVN001 will lay the foundation for the clinical application of SCS technology, extending its utility to a broader range of retinal disease treatments, ultimately enhancing the quality of life for patients."

The leading principal investigator for this clinical trial, Professor Yang Peizeng, an uveitis expert in China, who also serves as the Head of Ophthalmology at the First Affiliated Hospital of Chongqing Medical University and Director of the Chongqing Key Laboratory of Ophthalmology, commented, "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. Arctic Vision's ARVN001, utilizing innovative drug delivery technology, aims to directly deliver medication to the suprachoroidal space, potentially mitigating these risks and enhancing treatment effectiveness. We hold a very positive outlook for this innovative therapy."


Arctic Vision will continue to actively advance the clinical development of 锋脉®/ARCATUS® (ARVN001) in China, collaborating with various stakeholders to enhance the accessibility of this innovative therapy for Uveitic Macular Edema patients.


About Macular Edema Associated with Uveitis (UME)

Uveitis is a set of ocular inflammatory conditions and one of the major causes of visual morbidity. Macular edema (ME) is a common complication in patients with uveitis, which is characterized by a build-up of fluid in the macula, the area of the retina responsible for sharp, straight-ahead vision. UME is the leading cause of vision loss and blindness in uveitis patients and can occur from uveitis affecting any anatomic location – anterior, intermediate or posterior – or panuveitis. There are millions of patients suffering from uveitis in China, representing one of the leading causes of visual impairment among the working-age population. ARVN001 is the world’s first approved treatment for macular edema associated with uveitis.


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 obtained exclusive development and commercialization rights for XIPERE™ (ARVN001) in the Greater China region (Mainland China, Hong Kong, Macau, and Taiwan) and South Korea. In August 2021, Arctic Vision secured exclusive rights for ARVN001 in the ten ASEAN countries and India. In September 2021, Arctic Vision further expanded the ARVN001 territory to include Australia and New Zealand.


In addition to the Uveitic Macular Edema indication, Arctic Vision is also developing the indication of Diabetic Macular Edema 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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