Eyenovia submits new drug application for MydCombi
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Eyenovia Inc. announced that it submitted a new drug application to the FDA for its fixed combination mydriatic agent, MydCombi.
MydCombi was designed to deliver a micromist application of two mydriatic medications that limit discomfort, drug overflow and inadvertent contact with the eye, the company said in a press release. The NDA submission is based on data from the MIST-1 and MIST-2 phase 3 studies that showed approximately 94% of eyes treated with microdosed phenylephrine 2.5% and tropicamide 1% achieved a 6 mm or greater dilation at 35 minutes post-instillation. Adverse events were infrequent, Eyenovia said in the release.
“The NDA application for MydCombi represents a milestone for Eyenovia. 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,” Sean Ianchulev, CEO and chief medical officer of Eyenovia, said in the release. “MydCombi, delivered by our proprietary Optejet touchless dispenser, may have several advantages over the current standard of care for in-office mydriasis that are especially important in today’s environment. With no protruding parts and recessed nozzle and shutter, Optejet’s design enables touch-free mydriasis and helps reduce the risk of cross contamination.”
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