Eyenovia Eyes Cost-Cutting Measures Amid Disappointing Study Results

Eyenovia Inc.’s CHAPERONE study has not met its primary endpoint, forcing the ophthalmic tech firm to possibly consider a reverse merger to reduce expenses and maximize shareholder value.

An independent Data Review Committee (DRC) found the trial did not meet its primary endpoint of a less than 0.5 diopter progression in visual acuity over three years. CHAPERONE is Eyenovia’s Phase 3 study evaluating its proprietary drug-device combination of low-dose atropine in the Optejet dispensing platform as a potential treatment for pediatric progressive myopia.

The DRC reviewed the safety and efficacy data from 252 evaluable patients. The DRC found myopia progression rate 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,” Eyenovia CEO Michael Rowe said. “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 work on this program.”

In light of the study results, the company is considering various steps to maximize stakeholders value, reduce expenses, and evaluate its strategic options. Those options may include a business combination, reverse merger, asset sales, or a combination of the aforementioned alternatives.

Eyenovia Inc. is an ophthalmic technology company developing and commercializing products leveraging its proprietary Optejet topical ophthalmic medication dispensing platform. The Optejet is targeted at chronic front-of-the-eye diseases due to its ease of use, enhanced safety and tolerability, and potential for superior compliance. The company’s current commercial portfolio includes clobetasol propionate ophthalmic suspension, 0.05%, for post-surgical pain and inflammation, and Mydcombi for mydriasis.