Arctic Vision’s Phase III clinical trial of ARVN002 (Atropine Microdose Ophthalmic Solution) is the first phase III clinical trial of Microdose Array Print (MAP™) approved in China for the treatment of myopia. This marks yet another successful expansion of Arctic Vison’s MAP™ technology in the field of ophthalmic therapeutics. Shanghai, China, September 28, 2022 – Arctic Vision, a China-based biotech company focused on innovative ophthalmic therapies, today announced that the first patient has been enrolled in a Phase III clinical study evaluating ARVN002, a proprietary microdose formulation of atropine used with the innovative microdose delivery platform Optejet®, as a treatment for progressive myopia in China. The Phase III study to evaluate the efficacy and safety of ARVN002 in treating progressive myopia is led by China’s renowned ophthalmology leader and Principal Investigator, Professor Jia Qu, who also serves as the President of the Eye Hospital of Wenzhou Medical University. ARVN002, also known as MicroPine in the United States, is an innovative microdose atropine therapy widely recognized for its efficacy in the prevention and treatment of progressive myopia. When used with Optejet®, an innovative microdosing delivery device with Microdose Array Print (MAP™) proprietary technology, a fast and precise dose of 8μL of medication can be delivered to the cornea in approximately 80 milliseconds-using about 80 per cent less medication than conventional eyedroppers. Optejet® is also Bluetooth-enabled and compatible with smart electronics and mobile-health technology, which could enhance patient compliance, and patients and family members to conveniently track and manage their eye health. According to the National Health and Medical Commission1, 52.7 per cent of Chinese children and adolescents suffer from myopia in 2020. Early age myopia remains a significant eye health challenge, with the prevalence of myopia expected to increase 9.3 per cent as children progress through each grade in primary school. In addition, the prevalence of high myopia, or extreme nearsightedness, is accelerated with each grade year. 1.5 per cent of six-year-old children in China suffer from high myopia, and 17.6 per cent of high school students in China suffer from high myopia. High myopia may lead to myopic retinopathy, retinal detachment, cataract, glaucoma, and other serious complications. In severe cases, it may even cause blindness. Professor Jia Qu, the Principal Investigator and renowned leader in China’s ophthalmology sector – President of Eye Hospital of Wenzhou Medical University said, “The management of myopia in China is therefore critical-as it carries huge socioeconomic burden and significant impact on quality of life for patients. Effective, precise, safe, and high compliance therapy for myopia is significant to patients, families, and society. I am excited to lead the clinical study of this innovative treatment for progressive myopia and look forward to the approval of ARVN002 in the near future.” Dr. Liu Qing, Co-Founder and Chief Medical Officer at Arctic Vision noted, “Myopia prevention and control is a critical pathway noted in China’s national strategy, with children and adolescents specifically listed as key groups of concern in the ‘14th Five-Year Plan for National Eye Health (2021-2025) ’released this year. We are therefore extremely pleased with the momentous clinical step forward for ARVN002. It further cements the strengths of Arctic Vision’s core MAP™ technology and marks the successful expansion of the technology in the field of ophthalmic treatment following our progress using MAP™ technology to treat presbyopia. Our focus now is to keep working to make this cutting-edge technology accessible to more people, so we can benefit more myopia patients, and support the nation’s efforts to control and prevent myopia.” Arctic Vision obtained an exclusive license in August 2020 for the development and commercialization of ARVN002 (MicroPine) in Greater China and South Korea from Eyenovia, a U.S.-based clinical-stage biopharma company.
Reference : 1.NHC’s Press Conference on July 13th, 2021: Introduction of children myopia control and students health during summer vacation. Retrieved Jul 30, 2021, from http://www.nhc.gov.cn/xwzb/webcontroller.do?titleSeq=11389&gecstype=1
2.Pasquale LR, Lin S, Weinreb RN, et al. Latanoprost with high precision, piezo-print microdose delivery for IOP lowering: clinical results of the PG21 study of 0.4 µg daily microdose. Clin Ophthalmol. 2018 Nov 28; 12:2451-2457.
－ End － About ARVN002 ARVN002 (MicroPine) is currently being developed for progressive myopia. ARVN002 is designed to bring forth comfort and ease-of-use for patients. ARVN002 is anticipated to result in low systemic and ocular drug exposure. A therapeutic evidence assessment and review by the American Academy of Ophthalmology published in 2017 indicates Level 1 (highest) evidence of efficacy for the role of low dose atropine for progressive myopia (Ophthalmology2017;124:1857-1866; Ophthalmology 2016; 123(2) 391:399). For more research, please refer to the feasibility dose-finding atropine studies: ATOM 1; ATOM 2; LAMP (Independent Collaborative Group Trials) About Optejet® Optejet uses high-precision piezo-print technology to deliver approximately 8μL of drug, consistent with the capacity of the tear film of the eye. The volume of ophthalmic solution administered with the Optejet is 80% less than that delivered using conventional eye drops, thus reducing overdosing and exposure to drug and preservatives. Eyenovia's patented microfluidic ejection technology, MAP™ is designed for fast ocular surface delivery, where medication is dispensed as an array of microdroplets to the ocular surface in approximately 80 milliseconds, faster than the ocular blink reflex. Ease of use and successful delivery of medication by Optejet has been demonstrated in more than 85% of the attempts after basic training in a variety of clinical settings compared to 40 – 50% with conventional eyedroppers2. Additionally, its smart electronics and mobile e-health technology are designed to track and enhance patient compliance.
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 firstname.lastname@example.org