Shanghai, China, July 26, 2024 – Arctic Vision, a China-based biotech company focused on innovative ophthalmic therapies, today announced positive topline results of its Phase III clinical trial of ARCATUS® (ARVN001), a triamcinolone acetonide suprachoroidal injectable suspension, for the treatment of Uveitic Macular Edema (UME) 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 was officially accepted in Australia and Singapore.

The Phase III trial in China is a double-blind, randomized, placebo-controlled study designed to assess the efficacy and safety of ARCATUS® (ARVN001) in UME patients. This is the first registrational clinical trial for UME in China. The trial successfully met the primary endpoint and secondary endpoints, demonstrated significantly better visual acuity improvement and edema control in treatment arm than the sham arm, coupled with favorable tolerability and safety profile. In the study, 38.5% of ARVN001-treated patients gaining 15 ETDRS letter or more in vision vs 9.4% in the sham group, and Central Subfield Thickness (CST) reduction was 204.3 microns in ARVN001-treated patients vs 1.6 microns in the sham group at week 24. Both reached statistical significance (p<0.001). Furthermore, the mean BCVA gain were rapid with 9.6 letters at week 4 and continue to improve to 12.2 letters at week 24. Similarly, the CST changes were rapid, achieving over 200 microns reduction at week 4 and maintained the reduction to week 24. There were no ocular SAEs or new safety signals reported.

The leading principal investigator for this clinical trial, Professor Yang Peizeng, a uveitis expert in China, who also serves as the director of Henan Eye Hospital, commented, "The positive topline results of the Phase III clinical trial of ARCATUS® (ARVN001) highlight the potential of this innovative therapy for the treatment of UME. The innovative drug delivery technology ARVN001 utilizes delivers medication to the suprachoroidal space directly, which promises the potent efficacy of corticosteroids while reduces the risk of adverse events commonly arise from ocular steroid usage, such as cataracts, intraocular pressure elevation, and glaucoma, and therefore alleviates the treatment burden for the patients. We hold a very positive outlook for this innovative therapy and look forward to the early approval and marketing launch to benefit more patients.”

Dr. Qing Liu, Co-founder and Chief Medical Officer of Arctic Vision, stated, "We’re glad to see positive topline results of the Phase III clinical trial for ARCATUS® (ARVN001). This marks another step closer to filling the gap of drug therapy for uveitis macular edema treatment in China. We remain committed to advancing the R&D development and marketing of ARVN001 in China to address the unmet need for UME treatments. We believe it will benefit millions of families and reduce the burden on society.

This innovative medication employs the patented Suprachoroidal Space Microinjection (SCS Microinjector®) 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, with the advantage in precision, targeting, and potency. In recent years, SCS has been proven as a promising drug delivery technology. We believe that ARCATUS® (ARVN001) will make a positive contribution to China's healthcare development and bring hope to more families with retina & vitreous disease. 

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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.

For more information, please visit https://www.arcticvision.com

Investor and Media Contact: 

Communications@arcticvision.com