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.


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