Eyenovia Announces NDA Submission For MydCombi - Quick Facts

(RTTNews) - Eyenovia, Inc. (EYEN) has submitted a New Drug Application to the U. S. FDA for MydCombi, a fixed combination pupil dilation agent. The NDA submission was based on the MIST-1 and MIST-2 studies. The NDA submission follows the initial enrollment of the VISION-1 study, phase 3 study for MicroLine in presbyopia, with top-line data expected the first half of 2021.

"The NDA application is the first of our three late-stage programs to complete Phase 3 studies leading to this FDA submission. If approved, MydCombi could be available late next year or early 2022 and improve a common clinical practice that has not advanced in nearly a century," said Sean Ianchulev, CEO of Eyenovia.