Arctic Vision Announces CDE Approval of Phase III Clinical Trial for ARVN002, a Novel Microdose Atropine Therapy for Pediatric Progressive Myopia

Recently, ArcticVision announced that the Investigational New Drug (IND) application for the Phase III clinical trial of its innovative ophthalmic drug delivery therapy ARVN002 (micro-dose atropine ophthalmic solution) for progressive myopia in children has been approved by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). This marks ArcticVision's second IND approval, following the approval of the Phase III clinical trial for its novel suprachoroidal injection therapy ARVN001 for uveitic macular edema (UME).

This Phase III clinical trial aims to evaluate the efficacy and safety of ARVN002 in controlling myopia progression in pediatric and adolescent patients with myopia. Myopia is a refractive error primarily caused by an elongation of the axial length of the eyeball. In recent years, myopia among children and adolescents has become an increasingly severe global health concern, particularly in Asia. According to the latest statistical data¹ released by the National Health Commission in July 2021, the overall prevalence of myopia among children and adolescents in China reached 52.7% in 2020. The myopia rate among 6-year-old children nationwide exceeded 9% across all regions, underscoring the persistent challenge of early-onset myopia. Beyond imposing a substantial socioeconomic burden, progression to high myopia may precipitate severe, vision-impairing complications that significantly compromise patients' quality of life. Since 2018, following the promulgation of a series of policy documents—including the National Health Commission’s *Guidelines for the Prevention and Treatment of Myopia* and the interministerial *Comprehensive Implementation Plan for the Prevention and Control of Myopia in Children and Adolescents*—myopia prevention and control has been elevated to a national strategic priority.

ARVN002 (known as MicroPine in the United States) is a novel microdose atropine therapy for myopia. The efficacy of low-concentration atropine in slowing myopia progression has been extensively validated. Building on this foundation, ARVN002 innovatively integrates it with the cutting-edge microdose delivery system, Optejet®. Utilizing patented Microdose Array Print (MAP™) technology, the system rapidly and uniformly delivers precise micro-doses of medication to the ocular surface. The administered volume per dose is significantly reduced compared to traditional eye drops, thereby minimizing ocular and systemic safety risks associated with unnecessary overdosing and enabling more efficient, precise, and safe drug delivery. The delivery system also features a built-in Bluetooth module that connects to mobile devices, with smart operation and personalized settings designed to further enhance patient experience and medication adherence.

Dr. Eddy Wu (Haidi Hu), Ph.D., Founder, Chief Executive Officer and Director of Arctic Visonsaid: "The approval of the Phase III clinical trial application for ARVN002 not only signifies significant progress in our clinical development in the field of myopia treatment, but also brings us one step closer to our dual-engine strategic goal of addressing unmet medical needs and benefiting a broader population of ophthalmic patients."

Dr. Liu Qing, Chief Medical Officer, Arctic Visonstated: “The IND approval for the Phase III clinical trial marks a significant milestone for both ARVN002 and the micro-matrix drug film technology. We look forward to collaborating closely with clinical ophthalmology experts to initiate and complete this clinical study as soon as possible, bringing this innovative therapy to children with myopia and their families at the earliest opportunity.”

In August 2020, Arctic Vison entered into an exclusive licensing agreement with the U.S.-based Eyenovia, securing the rights for the clinical development and commercialization of ARVN002 (MicroPine) for controlling myopia progression and ARVN003 (MicroLine) for treating presbyopia in the Greater China region (mainland China, Hong Kong, Macau, and Taiwan) and South Korea. The Phase III clinical trial of MicroPine in the United States is currently underway, with the first patient enrolled in June 2019.

Responsible Editor: Liuli

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