Eyenovia, Inc. (NASDAQ: EYEN) announced that its Phase 3 CHAPERONE study, designed to evaluate a drug-device combination of low-dose atropine delivered via the Optejet platform for treating pediatric progressive myopia, did not meet its primary efficacy endpoint. The announcement follows a review of the study data by an independent Data Review Committee (DRC).
The CHAPERONE trial aimed to demonstrate that the treatment could limit myopia progression to less than 0.5 diopters over a three-year period. The DRC's analysis, which included data from 252 evaluable patients, revealed that there was no statistically significant difference in the rate of myopia progression between the two active treatment arms (0.01% and 0.1% atropine ophthalmic metered spray) and the placebo group.
Safety Profile
According to the press release, the safety analysis indicated that all dosages of atropine and the placebo were well-tolerated, with a mild and infrequent adverse event profile. However, full study data has not yet been released to Eyenovia.
Company's Response
"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."
Strategic Review
In light of these results, Eyenovia is considering various measures to maximize value for stakeholders, reduce expenses, and evaluate strategic options. These options may include a business combination, reverse merger, asset sales, or a combination thereof. The company plans to provide further updates after completing its strategic 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 chronic front-of-the-eye diseases, offering ease of use, enhanced safety and tolerability, and improved compliance. 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 other indications, including dry eye.
