July 30, 2021 – Arctic Vision announced the clearance of the Investigational New Drug (IND) application for Phase III study of ARVN002 (Atropine Microdose Ophthalmic Solution) to control the progression of paediatric myopia by the Center for Drug Evaluation, China National Medical Products Administration (CDE, NMPA). This is the second IND clearance for Arctic Vision since the first for the Phase III trial of ARVN001 for the treatment of Macular Edema associated with Uveitis (UME). The main objective of the Phase III clinical trial is to evaluate the efficacy and safety of ARVN002 in children with progressive myopia. Myopia is a refractive error primarily caused by an increase in the axial length of the eye.
In recent years, paediatric myopia has grown to be an increasingly prominent healthcare problem throughout the world, especially in Asia. Since the announcement of a series of policies in 2018 by the China NHC and relevant institutions, myopia prevention and control has become an important national objective in China. According to the latest statistics released by the China National Health Commission (NHC) in July 2021, the overall myopia rate among children and adolescents in China is 52.7% in 2020, and the myopia rate among 6-year-olds in urban areas across the country are above 9%. In addition to social and financial burdens, myopia may lead to complications that seriously compromise visual function and have significant impact on patients' quality of life.
ARVN002, known as MicroPine in the United States, is an innovative Atropine microdose therapy for paediatric myopia. Efficacy of low-dose atropine for myopia progression control has been widely validated. ARVN002 uniquely incorporates the low-dose formulation with Optejet®, an innovative microdosing delivery device. Optejet uses Microdose Array Print (MAP™), a patented technology that enables a fast and even distribution of a low dose of medication onto the eye surface. Compared with doses with traditional eye drops, administration with Optejet® greatly reduces the drug volume and avoids topical and systemic safety risk caused by overdosing. Furthermore, Optejet connects via Bluetooth with mobile devices to monitor and improve patient compliance. Dr. Eddy (Hoi Ti) Wu, Founder, CEO and Board Director of Arctic Vision, commented, “The IND clearance for ARVN002 marks significant progress in the development a novel treatment for myopia and a major stride forward in Arctic Vision’s dual-engine growth strategy, that addresses both high unmet clinical needs and broad ophthalmic patient populations.” Dr. Qing Liu, Chief Medical Officer of Arctic Vision, commented: “The IND clearance of Phase III study is a tremendous milestone for the clinical development of ARVN002 and MAP technology. We look forward to working closely with ophthalmologists and investigators to advance the Phase III study and bringing this innovative therapy to China and Asia as soon as possible, so that myopic children and their families can be benefited from this innovative solution for myopia treatment.” In August 2020, Arctic Vision obtained exclusive license for the development and commercialization of ARVN002 (MicroPine) and ARVN003 (MicroLine) in Greater China and South Korea from Eyenovia, a US-based clinical stage biopharma company. Eyenovia’s Phase III trial of MicroPine in the US is currently underway, and the first patient was enrolled in June 2019. About ARVN002 (MicroPine) 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® Eyenovia's 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 95% 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 from 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. Arctic Vision Media Contact firstname.lastname@example.org Reference . 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.