SHANGHAI, China, May 31, 2021 -- Arctic Vision today congratulates its collaboration partner Eyenovia, Inc. (NASDAQ: EYEN), for the announcement of positive topline results and reaching the primary endpoint for their VISION-1 Phase 3 clinical study of MicroLine (referred to as ARVN003 in Greater China and South Korea), a proprietary pilocarpine micro-dosing formulation indicated for the temporary improvement of near vision in adults with presbyopia.
The VISION-1 study met its primary endpoint, three-line distance-corrected near visual acuity at 120 minutes post-dosing. The most common adverse event was trace to mild hyperemia which was transient and occurred in about a fifth of patients. Full results will be presented at a future ophthalmic-focused medical meeting. Preparations are currently underway for a second Phase 3 registration study, VISION-2. Both studies will serve as the basis for a planned New Drug Application (NDA) submission to the US FDA.
Dr. Eddy (Hoi Ti) Wu, Founder, CEO and Board Director of Arctic Vision, commented, “We are proud of the progress our partners at Eyenovia have made in the clinical development of MicroLine. Its innovative formulation has the potential to deliver a new therapeutic option for patients with presbyopia that do not wish to wear reading glasses in certain situations. As their trusted partner for MicroLine, we congratulate them on this positive news and will continue our efforts to bring this novel asset to the market in Greater China and South Korea.”
“We are extremely pleased at the success of our VISION-1 study, marking another major milestone for our Micro-Array Print (MAP) platform technology,” stated Dr. Sean Ianchulev, Chief Executive Officer and Chief Medical Officer of Eyenovia. “Along with plans for VISION-2 in the coming months, we continue the development of the other two products based on MAP technology, including preparation of the potential FDA approval of MydCombi™ for mydriasis in the fourth quarter and full enrollment of the CHAPERONE study for paediatric myopia.”
In August 2020, Arctic Vision acquired an exclusive license from Eyenovia for the development and commercialization of MicroLine (for the treatment of presbyopia), as well as MicroPine (for the treatment of progressive myopia) in Greater China (mainland China, Hong Kong, Macau, and Taiwan) and South Korea.
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About the VISION Trials
The VISION trials are Phase 3, double-masked, placebo-controlled, cross-over superiority trials that will enroll participants with presbyopia. The primary endpoint is binocular distance corrected near visual acuity.
About MicroLine /ARVN003
Eyenovia’s MicroLine is a proprietary microdosed formulation of pilocarpine intended for the “on demand” improvement of near vision in people with presbyopia, delivered via the Company’s Optejet® dispenser. Providing high precision microdosing at approximately 1/5 the drug volume of a traditional eye dropper, the Optejet is designed to deliver targeted, consistent doses more conveniently than typical eyedroppers.
About Presbyopia
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[1]. Current treatment options are typically device or surgery-based, such as reading glasses, contact lenses, corneal procedures and multifocal intraocular lens implantation.
About Eyenovia, Inc.
Eyenovia, Inc. (NASDAQ: EYEN) is a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP) therapeutics. Eyenovia is currently focused on the late-stage development of microdosed medications for presbyopia, myopia progression and mydriasis. For more information, visit www.eyenovia.com.
About Arctic Vision
Arctic Vision is a China-based clinical stage specialty ophthalmology company with a leading portfolio of breakthrough technologies. The Company’s vision is to address unmet medical needs in ophthalmology with the discovery, development, and commercialization of innovative therapies in China, Asia and globally. Arctic Vision is led by an elite team of ophthalmic industry veterans with substantial and compelling R&D and commercial experience in both China and globally. For more information, please visit https://www.arcticvision.com.
Arctic Vision Media Contact:
communications@arcticvision.com
Reference :
[1] World report on vision. Geneva: World Health Organization; 2019. Licence: CC BY-NC-SA 3.0 IGO.
