This is the first clinical trial approved in China for presbyopia drugs and Arctic Vision's study marks the first patient enrollment in a Phase III clinical trial for presbyopia drugs in China. ARVN003 is expected to be the first approved drug for presbyopia in China.
SHANGHAI, July 4, 2022 /PRNewswire/ -- 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 ARVN003, a proprietary pilocarpine formulation leveraging its micro dosing platform Optejet®, as a treatment to temporarily improve vision in adults with presbyopia in China.
The Phase III study is double-masked, placebo-controlled, randomized, and multicenter trial evaluating the efficacy and safety of ARVN003 in achieving temporary improvement of vision in adults with presbyopia. It is the first clinical trial approved in China for presbyopia drugs and Arctic Vision's study marks the first patient enrollment in a Phase III clinical trial for presbyopia drugs in China.
Presbyopia is a physiological condition that makes it difficult to read and work in near distance. It is caused by the hardening of the lens and weakening of the ciliary muscle and often occurs with aging. Pre-presbyopia typically affects people between the ages of 35 and 45; early presbyopia affects people between the ages of 45 and 52; and late presbyopia, also known as absolute presbyopia, affects people over the age of 52. Today, nearly a quarter of the world's population is affected by presbyopia. With China's rapidly ageing population, the nation is seeing a year-on-year increase in the number of people suffering from presbyopia. Latest data revealed more than 390 million people in China are diagnosed with presbyopia in 2021.
Current treatment options for presbyopia include presbyopic reading glasses, contact lenses and surgery. However, due to limited treatment options and inadequate scientific understanding of the disease, many presbyopia patients in China do not receive intervention or vision correction in time. Untreated and escalated, presbyopia adversely impacts vision, quality of work and life, and the psychological well-being of middle-aged and elderly people. It might also increase financial burden on families and society.
Professor Jia Qu, the Principal Investigator and renowned leader in China's ophthalmology sector – President of Eye Hospital of Wenzhou Medical University said, "With China's rapidly aging population and a growing number of younger presbyopia patients, there is exponential demand for effective, safe, and convenient presbyopia treatments. We are excited to lead China's first clinical study of presbyopia medication and look forward to the approval of ARVN003 in the near future."
Dr. Qing Liu, Co-Founder and Chief Medical Officer at Arctic Vision added, "ARVN003's significant clinical progress is encouraging. This clinical achievement follows the successful dosing of the first DME patient in Asia with 锋脉® (Feng Mai) or Arcatus™ (ARVN001), and is testimony of the strength of Arctic Vision's proprietary microdose array print (MAP™) technology in the public eye health sector. We strive to make ARVN003 the first approved presbyopia drug in China, and benefit more presbyopia patients with innovative and diverse treatment options that will help them see and live better."
Arctic Vision obtained an exclusive license in August 2020 for the development and commercialization of ARVN003 (MicroLine) in Greater China and South Korea from Eyenovia, a U.S.-based clinical-stage biopharma company. In May 2021, Eyenovia announced positive results from the first Phase 3 MicroLine study, VISION-1, in the U.S. In that trial, the primary endpoint was achieved with MicroLine 2% statistically superior to placebo, determined by improvement in high contrast binocular distance corrected near visual acuity measured in low light conditions two hours after treatment.
ARVN003 is a proprietary pilocarpine formulation leveraging microdosing platform Optejet® for the pharmacologic treatment for presbyopia. Pilocarpine ophthalmic solution is known to constrict the pupil and improve near-distance vision by creating an extended depth of focus through its small aperture effect. The administration of pilocarpine uses high-precision microdosing platform Optejet® to provide improvement in near vision while enhancing tolerability and usability.
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 eyedroppers[i]. Additionally, its smart electronics and mobile e-health technology are designed to track and enhance patient compliance.
[i] 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.
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