Eyenovia Tanks: Shares Plummet 62% Following CHAPERONE Study Update, Failed Primary Endpoint

Eyenovia, Inc. (NASDAQ: EYEN) announced that an independent Data Review Committee has determined its Phase 3 CHAPERONE study is not meeting its primary three-year efficacy endpoint of less than 0.5 diopter progression in visual acuity. The study evaluated Eyenovia’s low-dose atropine treatment for pediatric progressive myopia using the Optejet dispensing platform.

Michael Rowe, CEO of Eyenovia stated, “We are disappointed that the DRC determined that the CHAPERONE study does not appear to be meeting its primary efficacy endpoint. 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.”

The committee’s review of data from 252 evaluable patients found no significant difference in myopia progression rates between the active treatment arms and placebo. Safety analyses indicated all dosages and placebo were generally well-tolerated with mild and infrequent adverse events. The company plans to discontinue the study, review the full dataset, and assess next steps, including potential strategic alternatives such as a business combination or asset sale.