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Arctic Vision Announces First Patient Dosed in Phase 1 Clinical Trial of ARVN001 for the Treatment of Diabetic Macular Edema (DME) in China
2022-03-03

Shanghai, China, March 3, 2022 – Arctic Vision, a China-based biotech company focused on innovative ophthalmic therapies, today announced the successful dosing of its first patient with 锋脉® or Arcatus™ (ARVN001), a triamcinolone acetonide suprachoroidal injectable suspension, in a clinical trial for the treatment of Diabetic Macular Edema (DME) in China. The dosing marks the first clinical application of Suprachoroidal Space (SCS®) microinjection on DME patients in Asia.

 

The Phase I clinical trial aims to evaluate the safety, pharmacokinetics, and efficacy of ARVN001 in the treatment of DME in China. This trial is set to be carried out in multiple Grade-A tertiary hospitals across China, with Shanghai General Hospital taking the lead. Professor Xun Xu, the Director of Ophthalmology Department of Shanghai General Hospital, and Professor Kun Liu, the Retina Division Director of Ophthalmology Department of Shanghai General Hospital are designated as the Principle Investigators (PIs).

 

Diabetes is a major health challenge in China. According to public record, China has over 140 million diabetes patients aged between 20-79[1], making China the country with the most diabetes patients in the world. In association, DME is a common complication of Diabetic Retinopathy (DR) and a major cause of vision loss and impairment in patients with diabetes.  Medical studies across different regions of China reveal that morbidity rate of DME among diabetes patients can be as high as 7.9 %, and is rising each year[2].

 

The current leading treatment options for DME include the laser photocoagulation and medication. One of the common drug treatments is the intravitreal administration of corticosteroid, which inhibits inflammation and helps improve vision and reduce edema. However, the drug is administered through intravitreal injections that creates unnecessary exposure to the anterior segment, which can cause higher post-treatment incidences of cataract and intraocular pressure elevation.

 

“DME is one of the major causes of visual impairment among diabetes patients. Providing relief to these visually-compromised patients in a precise, safe and effective way has been a continued medical challenge,” explained Professor Xun Xu. “This trial marks the very first application of SCS® administered therapy for DME patients in Asia. It has the potential to showcase the value of targeted drug delivery in improving drug efficacy and safety, as well as to become a breakthrough and viable option for DME clinical treatment.”

 

“Arctic Vision’s patented SCS Microinjection solution provides a highly targeted drug delivery to the suprachoroidal space while limiting unnecessary drug exposure to the anterior segment, and hence would reduce the associated adverse effects such as intraocular pressure elevation and cataract. I have high hopes on this innovative drug delivery system and DME therapy.” commented Professor Kun Liu. “We are very pleased to participate and take a leading role in this clinical trial, look forward to this new DME treatment option in near future after regulatory approval.”

 

Speaking on milestone, Chief Medical Officer of Arctic Vision, Dr. Qing Liu noted, “We are extremely excited about the potential of ARVN001. On top of the promising efficacy and safety profile demonstrated in previously completed clinical trials of multiple retina diseases treatment, we are continuing the efforts to further explore the benefits of SCS targeted drug delivery systems in the treatments of DME. We look forward to bringing this innovative therapy to the market as soon as possible, to benefit all Asian and Chinese DME patients.”

 

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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 acquired the exclusive license for the development and commercialization of XIPERE from U.S.-based ophthalmology player Clearside Biomedical, Inc. (NASDAQ: CLSD) in Greater China and South Korea, later expanding the license territory to include ASEAN countries and India, and subsequently Australia and New Zealand, in August and September 2021 respectively. ARVN001 is Arctic Vision’s project code for XIPERE.

 

In September 2021, CFDA has approved the second indication of ARVN001 for the treatment of diabetic macular edema (DME) to proceed to Phase I study. In November 2021, the first set of patients have been dosed in the Phase III study of ARVN001 for the treatment of macular edema associated with uveitis (UME) 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. For investor and media enquiries, please contact: communications@arcticvision.com

 



[1] International Diabetes Federation. IDF Diabetes Atlas, 10th edn. Brussels, Belgium: 2021. Available at: https://www.diabetesatlas.org

[2] Chinese Ocular Fundus Diseases Society, Chinese Ophthalmological Society, Chinese Medical Association. Guidelines for clinical diagnosis and treatment of diabetic retinopathy in China[J].Chin J Ophthalmol, 2014,50(11):851-865.


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