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.
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.