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FDA accepts IND application to begin Eyenovia myopia study

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Eyenovia announced the FDA accepted an investigational new drug application to initiate a phase 3 registration trial of MicroPine to reduce the progression of myopia in children.

According to a company press release, the U.S.-based, multicenter, randomized, double-masked CHAPERONE study will include 400 children between 5 and 12 years old. Participants will be randomly assigned to receive one of two MicroPine treatment concentrations or a placebo.

“The American Academy of Ophthalmology recently cited Level 1 evidence that topical lower doses of atropine treatment have demonstrated robust and sustained effect in slowing progressive myopia by up to 60% to 70%,” Sean Ianchulev, MD, MPH, Eyenovia’s CEO and chief medical officer, said in the release. “We believe that by combining the knowledge gained from these studies with our OpteJet, high-precision piezo-print microdose technology, we have the opportunity to potentially change the odds of progressive myopia.”

Trial enrollment is expected to begin in the first half of this year.