August 11, 2020
Eyenovia, which in June enrolled its first patient in its Phase 3 CHAPERONE study of progressive myopia, this month launched a new website to help parents of myopic children learn about the study and how to enroll.
The website is 4chaperone.com. It explains the purpose of the study and how will work, along with the eligibility requirements and what to expect during the study.
The CHAPERONE study is a U.S.-based, multi-center, randomized, double-masked trial that will enroll more than 400 children between 3-12 years of age. The study will investigate the safety and efficacy of MicroPine for the reduction of progressive myopia using Eyenovia’s proprietary atropine topical micro-formulation delivered by the Optejet dispenser. Subjects will be randomized to receive treatment with either of two MicroPine concentrations or a placebo. The primary endpoint of the study is the change in refractive error from baseline through 36 months. Currently, there are no FDA-approved therapeutics for the treatment of pediatric progressive myopia.
Eyenovia is targeting parents who are within driving distance of CHAPERONE study sites, using geolocated advertising and social media. The website will help parents pre-qualify and direct them to a local study site, many of which are university-associated optometry teaching centers, ophthalmic centers of excellence and/or well-known and regarded private clinics.
“I believe some of the current challenges faced by clinicians and families exploring myopia control with atropine are adherence and side effects with long term treatment,” said Dr. Danielle Iacono, Assistant Clinical Professor at SUNY College of Optometry and one of the Principal Investigators within the CHAPERONE study. “The Eyenovia micro-dosed atropine formulation to be evaluated in the CHAPERONE study delivers less drug in such a way that it could increase adherence to treatment and reduce adverse effects. Since these factors are paramount to the success of all ocular medication, I am excited to begin enrolling patients into this study, which at its conclusion will inform myself and other eye care providers as to the safety and efficacy of this novel approach to myopia control.”