Shanghai, China, Oct. 21st, 2022 - Arctic Vision today congratulates its collaboration partner Eyenovia, Inc. (NASDAQ: EYEN), for the announcement of positive results from its VISION-2 Phase 3 study of MicroLine (referred to as ARVN003 in Greater China and South Korea) as a potential topical, on-demand treatment for presbyopia. Eyenovia looks forward to meeting with the FDA in preparation for a potential new drug application (NDA) submission. In August 2020, Arctic Vision acquired an exclusive license from Eyenovia for the development and commercialization of MicroLine in Greater China (mainland China, Hong Kong, Macau, and Taiwan) and South Korea.
CEO and founder of Arctic Vision, Dr. Eddy Wu noted, “This is an important milestone for MicroLine's clinical development journey and we are delighted with the results from the clinical trial. Eyenovia's MicroLine treatment promises a new lease of life for presbyopic patients who are looking to stop their dependence on glasses. As a trusted partner of Eyenovia, we look forward to bringing this innovative treatment to Greater China and Korea, to benefit more patients.”
MicroLine (pilocarpine ophthalmic solution) is Eyenovia's investigational pharmacologic treatment for presbyopia, delivered via the Company's Optejet® dispenser. 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 VISION-2 study evaluated the safety and efficacy of Eyenovia's 2% pilocarpine micro-array print (MAP) formulation versus placebo, all administered via Eyenovia's proprietary Optejet® device. VISION-2 is the fourth Phase 3 study demonstrating the utility of the company's MAP technology in improving the therapeutic index of topical ophthalmic drugs.
Key highlights from the study include:
In a modified per-protocol analysis of evaluable patients, excluding a non-study related adverse event impacting pupil size and reactivity (new onset anisocoria), VISION-2 met its primary endpoint with a statistically significant proportion of subjects treated with MicroLine showing a 15-letter or more improvement in distance corrected near visual acuity (DCNVA) with less than a 5-letter loss in distance acuity versus placebo in low light conditions at two hours post-treatment.
The study also achieved all secondary endpoints at a statistically significant level.
MicroLine was very well tolerated. Adverse events were reported in fewer than 3% of patients, and all were mild and/or transient.
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.
Presbyopia is the non-preventable, age-related hardening of the lens, which causes a gradual loss of the eye’s ability to focus on nearby objects. It is estimated to affect nearly 1.8 billion people in the world. Current treatment options are typically device or surgery-based, such as reading glasses, contact lenses, corneal procedures and multifocal intraocular lens implantation.
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/
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