Industry News
Eyenovia Announces Discontinuation of Ophthalmic Medication Study
Eyenovia, Inc., a clinical-stage ophthalmic biopharmaceutical company, has discontinued its Phase 3 CHAPERONE study following a review by an independent Data Review Committee (DRC). The study aimed to evaluate the efficacy of atropine ophthalmic metered spray in slowing myopia progression in children.
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, Chief Executive Officer 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 response to these findings, Eyenovia has decided to discontinue the CHAPERONE study. The company plans to conduct a comprehensive review of the full data set before determining the next steps for the program. Potential strategic options under consideration include business combinations, reverse mergers, or asset sales.
