Eyenovia announced that it has initiated its MicroPine phase 3 program with the first patient enrolled in its CHAPERONE study, a US-based, multicenter, randomized, double-masked trial that will enroll more than 400 children between 3-12 years of age.
CHAPERONE 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—a back-of-the-eye disease characterized by uncontrolled sclero-retinal axial elongation leading to myopia and potential associated pathologic changes, such as retinal atrophy, macular staphylomas, retinal detachment, and visual impairment. It is estimated that close to 22% of young adults and children in the United States suffer from myopia, with progressive prevalence in the Caucasian population increasing more than 10-fold between the ages of 5 and 18 years, while in some regions in Asia, up to 80% of children are reported to be myopic.1,2
“We are very pleased to have initiated enrollment in our Phase 3 CHAPERONE study. 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, Eyenovia’s Chief Executive Officer and Chief Medical Officer, said in a company news release. “Level 1 evidence from recent academic, collaborative, randomized trials such as ATOM1, ATOM2, and LAMP have established that low concentration atropine eye drops can slow progressive myopia by up to 60-70%3-4 with an acceptable risk-benefit profile, and could be a game-changer in our efforts to fight the global myopia epidemic. 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.”
Dr. Pamela Gallin, Clinical Professor of Ophthalmology in Pediatrics and Director Emeritus, NY Presbyterian – Columbia University Medical Center added, “CHAPERONE will evaluate the benefit of slowing the progression of myopia with a microdose of low concentration atropine. This may reduce the problems associated with high myopia, including a range of retinal complications.”
“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,” commented 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.”