Arctic Vision Announces First Patient Dosed in China Phase III Clinical Trial of ARVN001 for Uveitic Macular Edema

Shanghai, November 19, 2021 /PRNewswire/ -- Arctic Vision, a biotechnology company focused on innovative ophthalmic therapies ("Arctic Vision"), announced that the first patient dosing has been successfully completed in the Phase III clinical trial in China for its lead pipeline product ARVN001 (triamcinolone acetonide suprachoroidal injectable suspension, known as XIPERE™ in the United States) for the treatment of uveitic macular edema. XIPERE™ is the world's first investigational therapy using suprachoroidal space microinjection (SCS Microinjection) technology, and its new drug application for the treatment of uveitic macular edema in the United States was approved by the FDA on October 25, and it is about to be launched.

Breakthrough Drug Delivery Technology: Suprachoroidal Space (SCS) Microinjection

Arctic Vison's ARVN001 study conducted in China is a randomized, double-blind, placebo-controlled Phase III clinical trial. The primary objective of the study is to evaluate the efficacy and safety of suprachoroidal injectable triamcinolone acetonide suspension (ARVN001) in patients with macular edema secondary to non-infectious uveitis (Uveitic Macular Edema, UME). This is the first registered clinical trial in China targeting uveitic macular edema and also marks the first application of suprachoroidal microinjection therapy in Chinese patients. The pivotal Phase III clinical study of ARVN001 in the United States is named PEACHTREE.¹The results showed that, at 24 weeks after receiving ARVN001 treatment, patients experienced significant improvement in vision, rapid and substantial reduction in macular edema with long-lasting effects, while the incidence of elevated intraocular pressure and cataracts was low, demonstrating the drug's favorable efficacy and safety.

The principal investigator of this clinical trial is Professor Yang Peizeng, Vice Chairman of the Ophthalmology Branch of the Chinese Medical Association, Director of the Municipal Key Laboratory of Ophthalmology in Chongqing, and Director of the Department of Ophthalmology at the First Affiliated Hospital of Chongqing Medical University. Professor Yang stated, "Local administration of glucocorticoids is one of the commonly used treatments for uveitis, but adverse reactions such as cataracts, increased intraocular pressure, and glaucoma often occur during treatment, causing trouble and burden for patients. ARVN001, an innovative therapy from Arctic Vision, delivers the drug directly to the suprachoroidal space while blocking its diffusion to the anterior segment of the eye, which is expected to significantly improve the bioavailability of the drug and reduce the risk of side effects. We are delighted to apply this therapy in clinical practice and look forward to bringing this new treatment option to patients with uveitic macular edema as soon as possible."

Dr. Qing Liu, Chief Medical Officer of Arctic Vision, mentioned: "We are very pleased to have taken another milestone step in the clinical development of ARVN001. The proven high efficiency, safety, and convenience of minimally invasive procedures in suprachoroidal injection therapy give us great confidence in the smooth progress of this trial. Currently, there are no approved drugs in China for the treatment of uveitic macular edema, and we hope to fill this gap as soon as possible. While addressing unmet patient needs, we also aim to lay the groundwork for the clinical application of suprachoroidal injection technology, which we plan to apply to more retinal disease treatments in the future, benefiting more patients and bringing about profound changes to the advancement of eye health."

About Uveitic Macular Edema (UME)）

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 factor leading to permanent vision loss caused by uveitis. Fluid accumulation in the macula, the area of the retina with the sharpest vision, leads to significant vision deterioration or even blindness. ARVN001 is the world's first and only approved treatment for macular edema secondary to uveitis.

About ARVN001

ARVN001 is a patented triamcinolone acetonide suspension specifically designed for suprachoroidal injection. It has been FDA-approved in the United States for the treatment of uveitic macular edema (UME) and is also being developed for other retinal diseases such as diabetic macular edema (DME). This innovative suprachoroidal delivery method allows the drug 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.

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 territorial rights for ARVN001, securing exclusive authorization in Australia and New Zealand.

In September 2021, Arctic Vison received the second clinical trial application approval for ARVN001 in China, with the indication being diabetic macular edema, and is currently preparing to conduct clinical trials.

About Arctic Vison

Arctic Vision 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, Asia, and globally, benefiting a wide range of patients with eye conditions. Arctic Vision 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 visitwww.arcticvision.com。

Investor and Media Contact:
Communications@arcticvision.com

¹ Yeh S, Khurana RN, Shah M, et al. Efficacy and Safety of Suprachoroidal CLS-TA for Macular Edema Secondary to Noninfectious Uveitis: Phase 3 Randomized Trial. Ophthalmology. 2020 Jul;127(7):948-955.

Further Reading:

1.       Arctic Vision's Partner Clearside Biomedical's Uveitis-Associated Macular Edema Treatment XIPERE™ (ARVN001) Approved for Marketing in the United States
2.       Arctic Vison Announces Further Expansion of Suprachoroidal Injection Therapy ARVN001 Rights to Australia and New Zealand with Exclusive Authorization
3.       Breakthrough in UME Treatment Bottleneck: SCS Suprachoroidal Injection, a Novel Therapy by Arctic Vision, Empowers a Brilliant Vision World
4.       Suprachoroidal New Formulation ARVN001 – The Uveitis Macular Edema Game-Changer