Eyenovia resumes phase 3 trial enrollment for progressive myopia treatment
Eyenovia resumed patient enrollment for its phase 3 study of a progressive myopia treatment following a pause due to the COVID-19 pandemic, according to a press release.
The U.S.-based, multicenter, randomized, double-masked CHAPERONE study is aiming to enroll more than 400 children between the ages of 3 and 12 years. Subjects will receive either one of two concentrations of MicroPine or placebo.
The study is evaluating the safety and efficacy of MicroPine in the reduction of progressive myopia using the company’s proprietary atropine topical micro-formulation, delivered by the Optejet dispenser. The study’s main endpoint is the proportion of eyes with less than 0.5 D increase in refractive error from baseline through 36 months.
“We are working in close partnership with our investigational sites as we advance to complete trial enrollment, which will depend on the continued improvement of the COVID-19 pandemic,” Sean Ianchulev, MD, MPH, CEO and chief medical officer of Eyenovia, said in the release.
Previously enrolled patients were monitored through telemedicine and remote monitoring processes during the pandemic, he said.