Phase 3 Trial of Eyenovia's Pediatric Myopia Treatment Falls Short of Primary Goal

Eyenovia has announced that its Phase 3 CHAPERONE study, aimed at treating pediatric progressive myopia, failed to meet its primary endpoint. The trial evaluated the company's proprietary drug-device combination using low-dose atropine delivered via the Optejet platform. A review by an independent Data Review Committee (DRC) led to the conclusion.

CHAPERONE Study Details

The CHAPERONE trial was designed to investigate whether Eyenovia's treatment could effectively slow the progression of myopia (nearsightedness) in children. The primary endpoint was a reduction in myopia progression, defined as less than a 0.5 diopter increase in visual acuity over a three-year period.

Study Findings

The DRC evaluated data from 252 pediatric patients and found no significant difference in the rate of myopia progression between the active treatment groups (0.01% and 0.1% atropine ophthalmic spray) and the placebo group.

Safety Analysis

While the treatment did not achieve its primary efficacy endpoint, the safety analysis revealed that all treatment doses, including the placebo, were generally well-tolerated. Reported adverse events were mild and infrequent. Eyenovia noted that the full dataset is still under review.

Michael Rowe, Chief Executive Officer of Eyenovia, expressed disappointment in the results, stating:

“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.”

Strategic Alternatives Under Consideration

In response to the trial outcome, Eyenovia is exploring various strategic alternatives to maximize stakeholder value. The company stated that options under consideration include:

       • Potential business combinations

       • Reverse mergers

       • Asset sales

       • A combination of these strategies

Eyenovia has also announced plans to reduce expenses while evaluating the best course of action.

Eyenovia will provide updates as it continues to analyze the full dataset from the CHAPERONE study and evaluate strategic options. The company aims to determine the best path forward in light of the study's findings.