Arctic Vision Announces First Patient Enrolled in Phase III Clinical Trial of ARVN003 for Presbyopia

This is the first clinical trial approved in China for Presbyopia Drugs and Arctic Vision’s Study Marks First Enrollment of Patients in a Phase III Clinical Trial for Presbyopia Drugs in China. ARVN003 is expected to be the first drug approved for presbyopia in China.

SHANGHAI, July 4, 2022 /PRNewswire/ — Arctic Vision, a Chinaa biotechnology company specializing in innovative ophthalmic therapies, today announced that the first patient has been enrolled in a Phase III clinical study evaluating ARVN003, a proprietary formulation of pilocarpine leveraging its Optejet® microdosing platform, as as a treatment to temporarily improve vision in adults with presbyopia in China.

The Phase III study is a double-blind, placebo-controlled, randomized, multicenter trial evaluating the efficacy and safety of ARVN003 in achieving temporary vision improvement in adults with presbyopia. This is the first clinical trial approved in China for Presbyopia Drugs and Arctic Vision’s Study Marks First Enrollment of Patients in a Phase III Clinical Trial for Presbyopia Drugs in China.

Presbyopia is a physiological condition that makes it difficult to read and work at close range. It is caused by hardening of the lens and weakening of the ciliary muscle and often occurs with age. Prepresbyopia usually affects people between the ages of 35 and 45; early presbyopia affects people aged 45 to 52; and late presbyopia, also called absolute presbyopia, affects people over the age of 52. Today, almost a quarter of the world’s population is affected by presbyopia. With China Rapidly aging, the country is experiencing a year-on-year increase in the number of people with presbyopia. The 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 insufficient scientific understanding of the condition, many presbyopic patients China do not receive timely intervention or vision correction. Untreated and aggravated, presbyopia negatively impacts vision, quality of work and life, and psychological well-being in middle-aged and elderly people. It could also increase the financial burden on families and society.

Teacher Jia Quprincipal investigator and recognized leader in China ophthalmology industry – President of Wenzhou Medical University Eye Hospital said, “With the rapid aging of the Chinese population and the growing number of young presbyopic patients, there is an exponential demand for effective treatments , safe and convenient presbyopia. We are delighted to lead China first clinical study of presbyopia drugs and we look forward to approval of ARVN003 in the near future.”

Dr. Qing Liu, co-founder and chief medical officer of Arctic Vision, added, “The significant clinical progress of ARVN003 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 demonstrates the strength of Arctic Vision’s proprietary Microdose Printing (MAP™) technology in the public eye health sector. We are working to make ARVN003 the first presbyopia drug approved in Chinaand benefiting more presbyopic patients with innovative and diverse treatment options that will help them see better and live better.”

Arctic Vision has obtained an exclusive license in August 2020 for the development and commercialization of ARVN003 (MicroLine) in Greater China and South Korea of Eyenovia, a US-based biopharmaceutical company. In May 2021Eyenovia announced positive results from MicroLine’s first Phase 3 study, VISION-1, in the United States. In this trial, the primary endpoint was achieved with MicroLine 2% statistically superior to placebo as determined by improvement in high contrast corrected binocular distance in near visual acuity. measured under low light conditions two hours after treatment.

About ARVN003

ARVN003 is a proprietary formulation of pilocarpine leveraging the Optejet® microdosing platform for the pharmacological treatment of presbyopia. Pilocarpine ophthalmic solution is known to constrict the pupil and improve near vision by creating an extended depth of field through its small aperture effect. Pilocarpine delivery utilizes the Optejet® high-precision microdosing platform to improve near vision while improving tolerance and usability.

About Optejet®

Optejet uses high-precision piezoelectric printing technology to deliver approximately 8μL of medication, consistent with the tear film capacity of the eye. The volume of ophthalmic solution delivered with the Optejet is 80% less than that delivered with conventional eye drops, reducing overdose and exposure to medications and preservatives. Eyenovia’s patented microfluidic ejection technology, MAP™, is designed for rapid delivery to the ocular surface, where drug is delivered as a network of microdroplets to the ocular surface in approximately 80 milliseconds, faster than the eye blink reflex. Ease of use and successful drug delivery by Optejet has been demonstrated in over 85% of attempts after basic training in various clinical settings, compared to 40-50% with conventional droppers[i]. Additionally, its smart electronics and mobile eHealth technology are designed to track and improve patient compliance.

[i] Pasquale LR, Lin S, Weinreb RN, et al. Latanoprost with high-precision piezoelectric imprint microdose delivery for IOP reduction: clinical results from the 0.4 mcg daily microdose PG21 study. Clin Ophthalmol. 2018 November 28; 12:2451-2457.

About Arctic Vision

Arctic Vision is a Chinaophthalmic biotechnology focused on breakthrough therapies, with a leading portfolio spanning pre-clinical to commercial stage products. Our vision is to provide innovative therapies in China, Asia and globally to address unmet clinical needs and benefit ophthalmology patients in general. Arctic Vision is backed by leading life science investors and led by an elite team of ophthalmic industry veterans with substantial regional and global experience in R&D and commercialization of ophthalmic products.

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SOURCE Arctic Vision

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