A review of study data by an independent Data Review Committee found that CHAPERONE is not meeting its primary three-year efficacy endpoint.
Company to discontinue study, review full data set, and evaluate next steps for the program.
Eyenovia, Inc. announced that a review of the CHAPERONE data by an independent Data Review Committee (DRC) found that the trial is not meeting its primary endpoint of a less than 0.5 diopter progression in visual acuity over three years.
CHAPERONE is Eyenovia’s phase 3 study evaluating its proprietary drug-device combination of low-dose atropine in the Company’s Optejet dispensing platform as a potential treatment for pediatric progressive myopia.
The DRC reviewed the safety and efficacy data from 252 evaluable patients. The DRC found that the rate of myopia progression was not significantly different between the two active treatment arms (0.01% and 0.1% atropine ophthalmic metered spray) and placebo.
In the safety analysis, all dosages and placebo appeared to be well-tolerated, with a mild and infrequent adverse event profile. Full study data has not yet been released to Eyenovia.
“We are disappointed that the DRC determined that the CHAPERONE study does not appear to be meeting its primary efficacy endpoint,” stated Michael Rowe, CEO of Eyenovia. “We plan to terminate the study, review the data more thoroughly, and evaluate next steps. On behalf of the entire company, I would like to express my sincere appreciation to the children, parents, caregivers and healthcare professionals who participated in this trial, as well as all the Eyenovia team members for their exceptional work on this program.”
In light of the results of this review, the company is considering a variety of steps to maximize value to all stakeholders, to reduce expenses and to evaluate its strategic options, which may include a business combination, reverse merger, asset sales or a combination of those alternatives. Further information will be made available once the evaluation of strategic options has been completed.