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

Recently, a biotechnology company focusing on innovative ophthalmic therapiesArctic Vison("Arctic Vison") announced that its core pipeline product, Fengmai^®/ ARCATUS^®(Arctic Vision Project Code: ARVN001) — Triamcinolone Acetonide Suprachoroidal Injection Suspension has successfully completed the enrollment of all subjects in the Phase III clinical trial for the treatment of Uveitic Macular Edema (UME). This significant milestone will further advance the drug as a revolutionary innovative therapy, offering new hope to patients in China suffering from Uveitic Macular Edema. The drug utilizes the world's first Suprachoroidal Space Microinjector (SCS Microinjector).^®) administration therapy, which has previously been approved by the U.S. FDA for marketing (U.S. trade name: XIPERETM), is the world's first and currently the only approved treatment for uveitic macular edema; additionally, the new drug application for this medication in Australia was formally accepted in July 2023.

This Phase III clinical trial conducted in China is a randomized, double-blind, placebo-controlled study, with the primary objective of evaluating Fengmai.^®/ 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. It offers numerous advantages such as precision, targeted delivery, and high efficiency. In recent years, suprachoroidal injection has been confirmed as a highly promising drug delivery method.

Dr. Liu Qing

Dr. Qing Liu, Co-founder and Chief Medical Officer of Arctic Vison, stated:"Arctic Vison"^®The successful completion of the Phase III clinical trial enrollment is of great significance for patients with uveitic macular edema and the entire ophthalmology field. We will continue to actively advance Fengmai.^®Accelerate the research and development as well as the market launch in China to quickly fill the gap in the domestic market for drugs treating uveitic macular edema. We also look forward to Arctic Vison's contributions.^®"While addressing the unmet needs of Chinese patients with uveitic macular edema, lay the foundation for the clinical application of suprachoroidal injection technology, expanding its use to more retinal disease treatment areas to improve patients' quality of life."

Professor Peizeng Yang

The principal investigator of this clinical trial is Professor Yang Peizeng, Vice Chairman of the Ophthalmology Branch of the Chinese Medical Association, Chairman of the Uveitis and Immunology Professional 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 Yang Peizeng stated:"Macular edema, as one of the most common and severe complications of uveitis, is also the primary factor leading to permanent vision loss caused by uveitis. It not only affects the patient's vision and quality of life but also imposes a heavy burden on their family and society. Local administration of glucocorticoids is currently one of the commonly used treatments for uveitis, but adverse reactions such as cataracts, elevated intraocular pressure, and glaucoma often occur during treatment, causing distress and burden to patients. Arctic Vision’s Pulse..."^®/ARCATUS^®(ARVN001) adopts a globally pioneering innovative drug delivery technology, delivering the drug directly to the suprachoroidal space, which is expected to reduce these risks and enhance treatment efficacy. We are very optimistic about the prospects of this innovative therapy."

Arctic Vison Suprachoroidal Injection Therapy ARVN001

（ARCATUS^®/Peak Pulse^®）

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

About Uveitic Macular Edema (UME)

Uveitis is a group of highly blinding ocular inflammatory diseases that affect the uvea, posing serious threats 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 the leading cause of permanent vision loss due to uveitis. Fluid accumulation in the macula, the area of the retina responsible for the sharpest vision, leads to significant vision impairment or even blindness. ARVN001 is the world's first and only approved treatment for macular edema secondary to uveitis.

About Arctic Vison^®/ARCATUS^®（ARVN001）

ARVN001 is a triamcinolone acetonide suprachoroidal injectable suspension specifically designed for suprachoroidal injection (brand name in China: 锋脉).^®/ 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, Macao, and Taiwan) and South Korea, with 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 territory for ARVN001 rights, gaining 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.

About Arctic Vison

Arctic Vison is a biotechnology company headquartered in China, focusing on innovative ophthalmic therapies. It has a portfolio of groundbreaking ophthalmic treatment technologies covering stages from early discovery to commercialization. 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 ophthalmic patients. Arctic Vison was founded with the support of professional investment firms in the life sciences sector and is managed by an elite team with extensive experience in global ophthalmic product research, development, and commercialization.

For more information, please visit

www.arcticvision.com。

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