Eyenovia's Late-Stage Pediatric Myopia Treatment Fails to Meet Primary Endpoint

Eyenovia announced that its phase 3 CHAPERONE study failed to meet its primary endpoint. The study was investigating Eyenovia’s proprietary drug-device combination, using low-dose atropine dispensed through the company's Optejet platform, as a potential treatment for pediatric progressive myopia. The conclusion came after a review by an independent Data Review Committee (DRC).

The CHAPERONE trial was designed to assess whether the treatment could reduce the progression of myopia (nearsightedness) in children, aiming for a less than 0.5 diopter increase in visual acuity over a 3-year period. However, after evaluating data from 252 patients, the DRC found no significant difference in the progression rate of myopia between the two active treatment groups (0.01% and 0.1% atropine ophthalmic spray) and a placebo.

The safety analysis of the study indicated that all treatment doses, including the placebo, were generally well-tolerated. The adverse events reported were mild and infrequent. Eyenovia noted that the full dataset has yet to be fully analyzed by the company.

“We are disappointed that the DRC determined that the CHAPERONE study does not appear to be meeting its primary efficacy endpoint." Michael Rowe, Chief Executive Officer of Eyenovia, said in a company news release. "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 findings, Eyenovia said it is exploring various strategic alternatives to maximize value for its stakeholders. According to the company, these options include potential business combinations, reverse mergers, asset sales, or a mix of these strategies. The company has also indicated that it will take measures to reduce expenses while it determines the best path forward.

Eyenovia plans to provide further updates as the evaluation of its strategic options progresses.