Eyenovia has enrolled the first patient in a phase 3 study of MicroPine for the treatment of progressive myopia, according to a press release.
The multicenter, double-masked CHAPERONE study will evaluate MicroPine, a topical atropine micro-formulation delivered with Optejet, the company’s piezo-print delivery technology. It will include more than 400 children between the ages of 3 and 12 years, and the primary endpoint is a change in refractive error from baseline to 36 months in two concentrations of MicroPine and placebo, the release said.
“This program could set some first-in-class precedents — not only as the first therapeutic indicated for myopic progression, but also the first topical therapy for a back-of-the-eye disease,” Sean Ianchulev, MD, MPH, Eyenovia CEO and chief medical officer, said in the release. “We plan to use the CHAPERONE study, along with the existing evidence from the previous academic collaborative trials, to submit for the FDA approval of MicroPine.”
There is currently no FDA-approved therapeutic for pediatric progressive myopia.