Shanghai, China, May. 8th, 2023 - Arctic Vision today congratulates its partner Eyenovia, Inc. (NASDAQ: EYEN), on the announcement of the U.S. Food and Drug Administration (FDA) approval of MydCombi™ (Arctic Vision’s project code ARVN004). Leveraging Eyenovia’s proprietary Microdose Array Print (MAP™) technology, MydCombi is developed for inducing mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired. This represents the first approved fixed dose combination of tropicamide and phenylephrine in the United States and also the first product using Eyenovia’s proprietary Optejet device to be approved by any regulatory authority.
Combined with MAP™ proprietary technology, Eyenovia’s Optejet microdosing delivery platform enables more precise, efficient and safer ocular surface delivery. MicroPine (Arctic Vision’s project code ARVN002), a microdose atropine solution for progressive myopia control, and MicroLine (Arctic Vision’s project code ARVN003), a microdose pilocarpine solution for presbyopia, also leveraging this platform. In September 2021, Arctic Vision entered an exclusive license agreement with Eyenovia for the development and commercialization of MydCombi™ in Greater China (Mainland China, Hong Kong, Macau, and Taiwan) and South Korea.
Dr. Eddy Wu, CEO and Founder of Arctic Vision, commented: “This is an important milestone for MydCombi™ and we are delighted with this breakthrough. FDA approval of Mydcombi provides critical validation of the Optejet, the microdose array print technology developed by Eyenovia for ocular therapeutics. This also serves as a strong endorsement for MicroPine for myopia and MicroLine for presbyopia, also leveraging this platform and unlocks significant potential in the future treatment of other ocular surface diseases. MydCombi™ can achieve rapid and long-lasting pupil dilation, improving the efficiency of comprehensive eye examinations, diabetic retinopathy, glaucoma, and other retina disease screening. As a trusted partner of Eyenovia, we look forward to bringing this innovative treatment to more patients in Greater China and Korea.”
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.
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