FDA accepts Eyenovia IND for Phase 3 MicroPine trial of myopia in children

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The FDA accepted Eyenovia’s (NASDAQ:EYEN) IND to initiate the Phase 3 CHAPERONE registration trial of its MicroPine treatment to reduce the progression of myopia in children.

The CHAPERONE study is a U.S.-based, multi-center, double-masked trial that will enroll more than 400 children between five and 12 years of age. Participants will be equally randomized to receive treatment with either of two MicroPine treatment concentrations or a placebo control arm.

In a statement, Dr. Sean Ianchulev, CEO and CMO, said the company plans to initiate enrollment for the Phase 3 trial in the first half of 2019.

MicroPine is Eyenovia’s micro-therapeutic topical formulation of atropine to target myopia progression, or near sightedness, a back-of-the-eye disease. Some 9% of children in the U.S. are believed to have myopia, while in Asian markets, up to 80% of children start out myopic.

There are currently no FDA-approved therapies to slow the progression of myopia, a condition that, if uncontrolled, can in some cases be associated with major pathologic changes, such as retinal atrophy, macular staphylomas, retinal detachment and visual impairment.

“Our work in this area follows in the footsteps of the ATOM 1, ATOM 2, and LAMP clinical studies performed by academic-collaborative groups,” he added. “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%.”

Dr. Ianchulev said 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.”

Separately, Ladenburg Thalmann analyst, Matthew Kaplan, reiterated his “buy” rating for Eyenovia and $35 price target. The stock was quoted at $4.54, up 36 cents, in afternoon trading on Feb. 6.

“We are impressed with the already existing data showing low dose atropine to be a safe and effective treatment for myopic progression and believe Eyenovia’s system could provide added benefit to the treatment (potentially to further mitigate side effects while maintaining the efficacy already observed),” Mr. Kaplan said.

Michelle Carr