A New Drug Application (NDA) has been submitted to the Food and Drug Administration (FDA) for MydCombi (phenylephrine/tropicamide; Eyenovia) for pharmacologic mydriasis.
MydCombi is a fixed microdose combination of phenylephrine and tropicamide that is delivered using the Company’s proprietary Optejet dispenser. The Company believes that MydCombi will reduce the number of doses required for dilation and potentially minimize dose-related side effects.
The NDA submission is supported by data from the phase 3 MIST-1 and MIST-2 studies that evaluated the efficacy and safety of a fixed combination of phenylephrine 2.5% and tropicamide 1% ophthalmic solution for pharmacologic mydriasis. Findings from both studies demonstrated that approximately 94% of treated eyes achieved 6mm or greater dilation at 35 minutes post-instillation.
As for safety, adverse events were infrequent (approximately 3% of patients); less than 1% of patients reported blurred vision, reduced acuity, photophobia or instillation site pain.
“With no protruding parts and recessed nozzle and shutter, Optejet’s design enables touch-free mydriasis and helps reduce the risk of cross contamination,” said Dr Sean Ianchulev, Chief Executive Officer and Chief Medical Officer of Eyenovia. “If approved, MydCombi could be available late  or early 2022 and improve a common clinical practice that has not advanced in nearly a century.”
For more information visit eyenovia.com.
Eyenovia submits New Drug Application to FDA for pharmacologic mydriasis with MydCombi targeting 80 million patient encounters in the U.S. annually. [press release]. New York, NY: Eyenovia, Inc.; December 29, 2020.