Eyenovia Enrolls First Patient in Phase 3 Study for Progressive Myopia

Eyenovia (NASDAQ:EYEN) has announced it has initiated its MicroPine Phase 3 program with the first patient enrolled in its CHAPERONE study.

As quoted in the press release:

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 – 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 III 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. 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,” commented Dr. Sean Ianchulev, Eyenovia’s Chief Executive Officer and Chief Medical Officer.

Click here to read the full press release.