Arctic Vision Completes Enrollment in China Phase III Trial of ARVN001 for Uveitic Macular Edema

Shanghai, China, September 28, 2023 — Arctic Vison ("Arctic Vison"), a biotechnology company focused on innovative ophthalmic therapies, announced today that its core pipeline product, PulseLight^®/ ARCATUS^®(Arctic Vison Project Code ARVN001) ——Arctic Vison's Triamcinolone Acetonide Suprachoroidal Injection Suspension Successfully Completes Enrollment of All Subjects in Phase III Clinical Trial for the Treatment of Uveitic Macular Edema (UME). This important milestone will further drive the drug to become a revolutionary innovative therapy, providing new hope for patients in China suffering from uveitic macular edema. The drug utilizes the world's first suprachoroidal space microinjector (SCS Microinjector).^®) Drug delivery therapy, previously approved for marketing by the U.S. FDA (U.S. trade name: XIPERE^TM), isThe world's first and currently only approved therapy for treating uveitic macular edema; while the new drug application for this medicine in Australia was officially accepted in July 2023.

This Phase III clinical trial conducted in China is a randomized, double-blind, placebo-controlled study, with its primary objective being to evaluate the efficacy of Arctic Vison's^®/ ARCATUS^®(ARVN001) Efficacy and Safety in the Treatment of Uveitic Macular Edema.This is the first registered clinical trial in China targeting uveitic macular edema.Arctic Vison^®/ ARCATUS^®(ARVN001) uses proprietary suprachoroidal microinjection (SCS Microinjection^®) technology, which allows drugs to rapidly and fully diffuse to the posterior segment of the eye with long-lasting effects, while significantly reducing adverse impacts on normal intraocular tissues, demonstratingPrecision, Targeted, EfficiencyAmong many advantages. In recent years, suprachoroidal injection has been confirmed as a highly promising drug delivery method.

Arctic VisonCo-Founder and Chief Medical Officer Liu QingDr. stated：

The principal investigator of this clinical trial isProfessor Yang Peizeng, Deputy Chairman of the Ophthalmology Branch of the Chinese Medical Association, Chairman of the Uveitis and Immunology Committee of the Ophthalmologist Branch of the Chinese Medical Doctor Association, and Director of the Department of Ophthalmology at the First Affiliated Hospital of Chongqing Medical University。

Professor Peizeng Yang stated：

"Macular edema, one of the most common and severe complications of uveitis, is also the primary factor leading to permanent vision loss caused by uveitis."Not only does it affect the patient's vision and quality of life, but it also imposes a heavy burden on their family and society.Topical administration of glucocorticoids is one of the commonly used treatments for uveitis currently, but adverse reactions such as cataracts, increased intraocular pressure, and glaucoma easily occur during treatment, causing trouble and burden for patients.And Arctic Vison Hong Kong Biotech Limited^®/ARCATUS^®(ARVN001) adopts the world's first innovative drug delivery technology, delivering the drug directly to the suprachoroidal space.Is expected to reduce these risks and improve treatment outcomes, we are very optimistic about the prospects of this innovative therapy.”

Arctic Vison has always been committed to providing breakthrough frontier technologies and innovations that meet consumer needs for China, Asia, and even the globe, to help patients and the public more effectively address eye health challenges and enjoy a pleasant life.

Uveitis is a group of highly blinding ocular inflammatory diseases that affect the uvea, posing a serious threat to patients' vision and quality of life, and imposing a heavy burden on patients, their families, and society. Macular edema is one of the most common and severe complications of uveitis and is the primary cause of permanent vision loss due to uveitis. Fluid accumulation leading to edema occurs in the macula, the area of the retina responsible for the sharpest vision, causing significant vision loss or even blindness. ARVN001 is the world’s first and only approved treatment for macular edema secondary to uveitis.

ARVN001 is a triamcinolone acetonide suprachoroidal injectable suspension (brand name in China: 锋脉) specifically designed for suprachoroidal injection.^®/ ARCATUS^®)), which has been approved by the FDA in the United States for the treatment of uveitic macular edema (UME), is also being developed for other fundus diseases such as diabetic macular edema (DME). This innovative suprachoroidal drug delivery method allows the medication to quickly and fully diffuse to the posterior segment of the eye with long-lasting effects, while significantly reducing adverse effects on normal intraocular tissues.

In March 2020, Arctic Vision acquired the exclusive rights for the development and commercialization of XIPERE™ in Greater China (Mainland China, Hong Kong, Macau, and Taiwan) and South Korea, under the project code ARVN001. In August 2021, Arctic Vision obtained the exclusive rights for ARVN001 in the ten ASEAN countries and India. In September 2021, Arctic Vision further expanded the territorial rights for ARVN001, securing exclusive authorization in Australia and New Zealand.

In addition to the ongoing development of the uveitic macular edema indication, Arctic Vision is also concurrently conducting clinical development for the diabetic macular edema indication.

Arctic Vision is a biotechnology company headquartered in China, focusing on innovative ophthalmic therapies. It has a portfolio of groundbreaking ophthalmic treatment technologies ranging from early discovery to commercialization stages. The company’s vision is to address unmet clinical needs in the field of ophthalmic diseases by providing innovative therapies in China, across Asia, and globally, benefiting a wide range of patients with eye conditions. Arctic Vision was founded with the support of specialized life science investors and is managed by an elite team with extensive experience in global ophthalmic product development and commercialization. For more information, please visit www.arcticvision.com.

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Communications@arcticvision.com

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