Shanghai, China, September 17, 2021 -- Arctic Vision, a China-based biotech company focused on innovative ophthalmic therapies, announced today that it will expand its exclusive license agreement with Eyenovia, Inc. (NASDAQ: EYEN) to include a third asset, MydCombi™, for development and commercialization in Greater China (mainland China, Hong Kong, Macau and Taiwan) and South Korea.
MydCombi™ (Arctic Vision’s project code ARVN004) is Eyenovia’s proprietary, first-in-class combination microdose formulation of tropicamide and phenylephrine for mydriasis (pupil dilation). MydCombi™ was developed leveraging the Optejet® dispenser, Eyenovia’s proprietary microdose array print (MAP™) formulation and delivery platform, to ensure consistent and easy application of two mydriatic medications in a quick, high-precision, and touchless, micro-mist application.
Pharmacologic mydriasis (pupil dilation) is part of the comprehensive eye exam, and is essential for diabetic retinopathy, glaucoma and retina disease screening. In two completed Phase III pivotal trials with MydCombi™, approximately 94% of treated eyes achieved rapid, sustained, and clinically significant mydriasis post-installation, and less than 1% of subjects reported stinging as an adverse event1. In the U.S., the New Drug Application (NDA) for MydCombi™ has been accepted for filing by the Food and Drug Administration (FDA) with PDUFA date scheduled for October 28th, 2021.
Dr. Eddy (Hoi Ti) Wu, Founder and CEO of Arctic Vision, commented, “We have made exciting progress in the clinical development of ARVN002 and ARVN003 since our collaboration with Eyenovia last year. As we continue to build our pipeline, MydCombi highlights our focus on cutting-edge and consumer-oriented technologies to improve eyecare in China and Asia.”
In August 2020, Arctic Vision entered into an exclusive license with Eyenovia for the development and commercialization of ARVN002 (MicroPine) for treatment of paediatric progressive myopia and ARVN003 (MicroLine) for presbyopia treatment in Greater China and South Korea. In China, IND applications for Phase III studies of ARVN002 and ARVN003 have both been cleared.
Eyenovia's Optejet microdose formulation and delivery platform for ocular therapeutics uses high-precision piezo-print technology to deliver approximately 8 μL 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 eyedroppers, thus reducing overdosing and exposure to drug and preservatives. Eyenovia's patented microfluidic ejection technology MAP™ (Microdose Array Print) is designed for fast and gentle ocular surface delivery, where solution is dispensed to the ocular surface as an array of microdroplets in approximately 80 milliseconds, beating the ocular blink reflex. Successful use of the Optejet has been demonstrated more than 85% of the time after basic training in a variety of clinical settings compared to 40 – 50% with conventional eyedroppers2. Additionally, its smart electronics and mobile e-health technology are designed to track and enhance patient compliance.
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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1 Wirta DL, Walters TR, Flynn WJ, Rathi S, Ianchulev T. Mydriasis with micro-array print touch-free tropicamide-phenylephrine fixed combination MIST: pooled randomized Phase III trials. Ther Deliv. 2021 Mar;12(3):201-214.
2 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. Clinical Ophthalmology. 2018 Nov 28; 12:2451-2457.