Shanghai, China – January 27th, 2025 – Arctic Vision, a China-based biotech company focused on innovative ophthalmic therapies, announced today that the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has formally accepted its New Drug Application (NDA) for ARCATUS® (Arctic Vision project code ARVN001) for the treatment of uveitic macular edema (UME). Utilizing the globally pioneering suprachorodial space microinjection technology (SCS Microinjector®), ARVN001 (known as XIPERE® in the U.S.) is the first and currently only approved suprachoroidal therapy to treat UME globally. It has already been approved by the Food and Drug Administration in the United States, Therapeutic Goods Administration in Australia, and the Health Sciences Authority in Singapore.
In China, the number of uveitis patients amounts to several million, with a significant proportion being among the middle-aged and young population1. Uveitic macular edema, one of the most prevalent and grave complications of this ophthalmic disorder, stands as the primary cause of permanent visual impairment2. The current primary treatment option for UME involves the local administration of corticosteroids. However, this approach often leads to adverse events such as cataracts, increased intraocular pressure, and glaucoma, causing distress and burden to patients3. As the first SCS® injection therapy, ARCATUS®(ARVN001) utilizes an innovative delivery platform to administer triamcinolone acetonide, enabling potent anti-inflammatory effects and also enhances the safety of the treatment, offering a promising new approach for a broader range of ophthalmic patients.
Dr. Qing Liu, Co-founder and Chief Medical Officer of Arctic Vision, stated:” As the first core product since the company's establishment, ARVN001 embodies the earnest expectations and efforts of all members. The acceptance of this product by the Center for Drug Evaluation (CDE) is undoubtedly a resplendent milestone in the company's development journey, symbolizing that the company's outstanding achievements in the research and development of innovative ophthalmic drugs have been authoritatively recognized. We will continue to make every effort to expedite the approval and market-launch process of ARVN001 in China, to bring a revolutionary solution to patients suffering from UME, meet the pressing clinical needs, and lead the innovation and development of ophthalmic therapies in China.”
References:
1. Yang Peizeng, Liu Yizhi. Ophthalmology[M]. Beijing People's Medical Publishing House, 2017:238-264.
2. Accorinti et al, Ocular Immunology & Inflammation 2019; 27: 169–80.
3. Karim et al, Clinical Ophthalmology 2013:7 1109–1144.
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. ARVN001 is the world’s first approved suprachoroidal 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., Australia and Singapore 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. 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) from Clearside Biomedical for 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.
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
