Eyenovia's Phase 3 CHAPERONE Study Fails to Meet Primary Endpoint for Pediatric Myopia
Key Insights
Eyenovia's CHAPERONE Phase 3 trial, evaluating low-dose atropine via Optejet for pediatric myopia (search), did not meet its primary endpoint of slowing myopia progression over three years.
An independent Data Review Committee found no significant difference in myopia (search) progression between the active treatment arms (0.01% and 0.1% atropine) and placebo.
Eyenovia plans to discontinue the CHAPERONE study, conduct a thorough data review, and assess strategic options, including potential business combinations or asset sales.
Eyenovia Inc. (NASDAQ: EYEN) announced that its Phase 3 CHAPERONE study failed to meet its primary efficacy endpoint. The study was designed to evaluate the effectiveness of low-dose atropine delivered via Eyenovia's Optejet dispensing platform as a treatment for pediatric progressive myopia (search).
The CHAPERONE trial aimed to demonstrate a less than 0.5 diopter progression in visual acuity over three years in children with progressive myopia (search). However, an independent Data Review Committee (DRC) found that the trial did not meet this primary endpoint after reviewing data from 252 evaluable patients.
Study Findings
The DRC's analysis revealed that there was no statistically significant difference in the rate of myopia (search) progression between the two active treatment arms, which included 0.01% and 0.1% atropine ophthalmic metered spray, and the placebo group. The safety analysis indicated that all dosages and the placebo were well-tolerated, with only mild and infrequent adverse events reported.
"We are disappointed that the DRC determined that the CHAPERONE study does not appear to be meeting its primary efficacy endpoint," stated Michael Rowe, Chief Executive Officer of Eyenovia. "We plan to terminate the study, review the data more thoroughly, and evaluate next steps."
Next Steps for Eyenovia
In light of these results, Eyenovia is considering various strategic options to maximize value for its stakeholders. These options may include a business combination, reverse merger, asset sales, or a combination of these alternatives. The company plans to provide further updates after completing its evaluation.
About Eyenovia and Optejet
Eyenovia, Inc. is an ophthalmic technology company focused on developing and commercializing products that utilize its proprietary Optejet topical ophthalmic medication dispensing platform. The Optejet is designed for ease of use, enhanced safety and tolerability, and improved compliance, targeting chronic front-of-the-eye diseases. Eyenovia's current commercial portfolio includes clobetasol propionate ophthalmic suspension, 0.05%, for post-surgical pain and inflammation, and Mydcombi® for mydriasis. The company also has licensing and development agreements for additional indications, including dry eye.