ARVN004

ARVN004 (MydCombi™) 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.


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.


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.


ADDRESS
@1Suite 906-908, 9F, Tower II, Century Link, 1196 Century Avenue, Shanghai, China @2Suite A09, 10th Floor, Twin Towers (East), B 12 Jianguomenwai Avenue, Beijing, China @3Suite 2305, 23/F, The Gateway Prudential Tower, Harbour City, No 21 Canton Road, Tsim Sha Tsui, Kowloon, Hong Kong
SUBSCRIBE TO OUR NEWSLETTER
Subscribe

To report a potential adverse event, please refer to the contact information below:

Global: globalsafety@arcticvision.com

Mainland China: safety.cn@arcticvision.com

Hong Kong, China: safety.hk@arcticvision.com

Copyright © 2022 Arctic Vision (Shanghai) Biotechnology Co., Ltd.