Eyenovia Explores Strategic Options After CHAPERONE Trial Misses Primary Endpoint

Eyenovia, Inc., a company specializing in ophthalmic technology, announced that an independent Data Review Committee (DRC) has assessed interim findings from the Phase 3 CHAPERONE trial. The trial, which evaluates Eyenovia’s low-dose atropine delivered via the Optejet platform for treating pediatric progressive myopia, is not meeting its primary goal of limiting visual acuity progression to less than 0.5 diopters over three years.  

The DRC reviewed safety and efficacy data from 252 patients and found no significant difference in the rate of myopia progression between the two treatment doses (0.01% and 0.1% atropine) and placebo. However, the safety analysis indicated that all doses and placebo were well-tolerated, with only mild and infrequent adverse events reported. The full results of the study are yet to be provided to Eyenovia. 

Michael Rowe, Chief Executive Officer of Eyenovia, said in a statement, “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, healthcare professionals who participated in this trial, and all the Eyenovia team members for their exceptional work on this program.”

Eyenovia is exploring various strategic options to maximize stakeholder value based on these findings. These options may include cost reduction measures, a potential business combination, reverse merger, asset sales, or a combination of these approaches. The company plans to share further updates once its strategic evaluation is complete.