Arctic Vision Announces First Asian Patient Dosed in Clinical Trial of ARVN001 (Fengmai®/Arcatus™) for Diabetic Macular Edema

March 3, 2022, Arctic Vision announced, Fengmai^®/Arcatus™ (ARVN001) (Triamcinolone Acetonide Suprachoroidal Injection Suspension, known as XIPERE™ in the United States) has completed the first patient dosing in a clinical trial in China for the treatment of Diabetic Macular Edema (DME). This is also the first DME patient dosing in the Asian region.

This study is a multi-center, open-label, single-arm Phase I clinical trial aimed at evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of suprachoroidal injection of triamcinolone acetonide suspension (ARVN001) in patients with diabetic macular edema. This clinical study will be conducted across multiple tertiary hospitals in China, with the leading unit being Shanghai First People's Hospital. The principal investigators (PIs) are Professor Xu Xun and Professor Liu Kun, both senior ophthalmologists at Shanghai First People's Hospital.

China is a major country afflicted with diabetes. Diabetic Macular Edema (DME), secondary to Diabetic Retinopathy (DR), is one of the severe chronic complications of diabetes, which can cause serious vision impairment or even blindness in diabetic patients. The latest authoritative data shows¹The number of people aged 20-79 with diabetes in China exceeds 140 million, ranking first globally. Based on epidemiological surveys across various regions of China,²The incidence of DME in diabetic patients can be as high as 7.9% and is still increasing year by year.

Current main treatments for diabetic macular edema include retinal laser photocoagulation and medication. In terms of medication, corticosteroids are one of the commonly used and effective treatments, which can reduce macular edema and improve vision through anti-inflammatory effects. However, the traditional method of administration is primarily intravitreal injection, and unnecessary exposure of the drug in the anterior segment after administration may lead to adverse reactions such as increased intraocular pressure and cataracts.

Professor Xu Xun, Director of Ophthalmology at Shanghai First People's Hospital, stated: "Diabetic macular edema is one of the leading causes of vision impairment in diabetic patients. For a long time, how to accurately, safely, and effectively improve the vision of DME patients has been a major challenge in treatment. This study is the first in Asia to apply an innovative suprachoroidal delivery anti-inflammatory therapy to DME patients, which is expected to demonstrate the value of targeted drug delivery in enhancing drug bioavailability and safety, offering a breakthrough option for the future clinical treatment of DME."

"The suprachoroidal microinjection therapy developed by Arctic Vision utilizes a patented SCS microinjector to deliver medication directly to the suprachoroidal space, targeting retinal and choroidal lesions while preventing drug diffusion to the anterior segment. This reduces the risk of increased intraocular pressure and cataract formation, making it an innovative drug delivery method and DME treatment that I highly endorse," stated Professor Kun Liu, Chief Physician of the Ophthalmology Center at Shanghai First People's Hospital. "We are thrilled to participate in and lead this research, and we look forward to the approval and market launch of this innovative therapy in the near future."

Arctic Vison on Fengmai^®"We are very excited about the potential of this product," emphasized Dr. Qing Liu, Chief Medical Officer of Arctic Vision: "We look forward to further validating the benefits of targeted drug delivery in Asian and Chinese patients, building on the efficacy and safety demonstrated in earlier DME clinical trials. We hope that through our efforts, we can quickly advance the clinical development and market entry of this innovative therapy to benefit a wide range of patients with diabetic macular edema."

References

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

2. Retina Group of Chinese Ophthalmological Society, Chinese Medical Association. Clinical Guidelines for the Diagnosis and Treatment of Diabetic Retinopathy in China (2014) [J]. Chinese Journal of Ophthalmology, 2014, 50(11): 851-865.