Eyenovia Resumes Recruitment of Phase III CHAPERONE Study for Progressive Myopia
NEW YORK, June 30, 2020 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP) therapeutics,
today announced that the Company has resumed patient enrollment for its Phase III CHAPERONE study for the treatment of progressive myopia, following a temporary pause due to the COVID-19
“We are excited to resume enrollment in our Phase III CHAPERONE study among nearly all of our clinical sites for the treatment of progressive myopia in children. Despite conditions caused by COVID-19, we continued to follow-up with and monitor previously enrolled CHAPERONE patients via telemedicine and remote monitoring processes. We are pleased to report that all patients previously randomized to treatment have continued to progress in the study. 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,” commented Dr. Sean Ianchulev, Eyenovia’s Chief Executive Officer and Chief Medical Officer. "
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 is investigating 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 proportion of eyes with < 0.5 D increase in refractive error from baseline through 36 months.
Eyenovia, Inc. (NASDAQ: EYEN) is a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP) therapeutics. Eyenovia’s pipeline is currently focused on the late-stage development of microdosed medications for presbyopia, myopia progression and mydriasis. For more Information please visit www.eyenovia.com.
About MicroPine for Progressive Myopia
MicroPine (atropine ophthalmic solution) is Eyenovia's first-in-class topical treatment for progressive myopia, a back-of-the-eye condition commonly known as nearsightedness. Progressive myopia is estimated to affect close to 5 million children in the United States who suffer from uncontrolled axial elongation of the sclera leading to increasing levels of myopia and in some cases major pathologic changes such as retinal atrophy, macular staphylomas, retinal detachment and visual impairment. MicroPine has been developed for comfort and ease-of-use in children. Microdose administration of MicroPine is anticipated to result in low systemic and ocular drug exposure. A recent therapeutic evidence assessment and review by the American Academy of Ophthalmology indicates Level 1 (highest) evidence of efficacy for the role of low dose atropine for progressive myopia (Ophthalmology 2017;124:1857-1866; Ophthalmology 2016; 123(2) 391:399).