Arctic Vision Secures Exclusive Rights for ARVN001 in ASEAN and India, Advances Innovative Suprachoroidal Therapy for Uveitic Macular Edema

SHANGHAI, China, August 15, 2021 -- Arctic Vision (hereinafter referred to as "Arctic Vision" or "Arctic"), a company focused on innovative ophthalmic therapies, announced that it has entered into a supplemental license agreement with its partner Clearside Biomedical, Inc. (NASDAQ: CLSD) (hereinafter referred to as "Clearside"), whereby the geographic coverage of the exclusive development and commercialization rights for its core product ARVN001 (triamcinolone acetonide suprachoroidal injection suspension, known as XIPERE™ in the United States) has been expanded from Greater China (Mainland China, Hong Kong, Macau, and Taiwan) and South Korea to include the ten ASEAN member states (Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam) and India.

ARVN001 is a patented suspension of the glucocorticoid triamcinolone acetonide, administered into the suprachoroidal space (SCS®) via the patented SCS Microinjector®. It is currently under development for the indication of uveitic macular edema. The US New Drug Application (NDA) for XIPERE was accepted by the FDA in May 2021, and a Phase III clinical trial in China is planned to commence in the second half of 2021.

Dr. Eddy Wu, Founder, Chief Executive Officer and Director of Arctic Vison, stated: “We are pleased to further deepen our collaboration with Clearside to expand the rights for ARVN001 in Asia. Overseas commercial expansion has always been a key component of Arctic Vison’s strategic roadmap, and incorporating ARVN001, a late-stage clinical candidate, into this framework will undoubtedly accelerate our progress. Going forward, with ARVN001 as a starting point, we will continue to strive to deliver innovative solutions to patients with ocular diseases across Asia through a combination of strategic in-licensing and in-house research and development.”

Dr. George Lasezkay, President and Chief Executive Officer of Clearside, commented: “We are delighted to expand our collaboration with ArcticVision. Over the past year, both parties have worked closely together and achieved positive progress. We believe that ArcticVision possesses robust clinical development and commercialization capabilities, and will successfully bring this innovative therapy to patients with uveitic macular edema in Asia.”

ARVN001

ARVN001 is a patented suspension of the glucocorticoid triamcinolone acetonide, specifically formulated for suprachoroidal injection, and is currently under development for the treatment of uveitic macular edema (UME). This innovative suprachoroidal delivery method enables rapid and extensive diffusion of the drug into the posterior segment of the eye with a sustained duration of action, while significantly minimizing adverse effects on normal intraocular tissues.

In March 2020, Arctic Vison secured the development and commercialization rights for XIPERE™ in Greater China (Mainland China, Hong Kong, Macao, and Taiwan) and South Korea, under the project code ARVN001. In December of the same year, Arctic Vison received approval from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for its Phase III clinical trial application for the treatment of uveitic macular edema.

ARVN001 has not yet been approved for marketing globally, and its US New Drug Application (NDA) was accepted by the FDA in May 2021.

Regarding Uveitic Macular Edema (UME)

Uveitis is a group of highly blinding ocular inflammatory diseases affecting the uvea. Macular edema is one of the most common complications in patients with uveitis, characterized by fluid accumulation and edema in the macula, the region of the retina responsible for the sharpest vision. Uveitic macular edema can be secondary to uveitis involving any anatomical segment of the eye (anterior, intermediate, posterior, or panuveitis) and is the leading cause of vision loss and blindness in uveitis patients.

Executive Editor: Liuli

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