Eyenovia Updates Phase 3 CHAPERONE Study

Eyenovia, Inc. (NASDAQ: EYEN), a company focused on ophthalmic technology, has announced significant results from its Phase 3 CHAPERONE study. The study, which was aimed at evaluating a treatment for pediatric progressive myopia using Eyenovia’s drug-device combination, did not meet its primary endpoint. The independent Data Review Committee (DRC) found that the trial failed to achieve the objective of less than 0.5 diopter progression in visual acuity over three years.

CHAPERONE involved 252 evaluable patients and compared two active treatment arms, 0.01% and 0.1% atropine ophthalmic metered spray, against a placebo. The DRC's review indicated that there was no significant difference in the rate of myopia progression between the treatment groups and the placebo. However, the safety analysis revealed that all doses and the placebo were well-tolerated, with only mild and infrequent adverse events reported.

Michael Rowe, Chief Executive Officer of Eyenovia, expressed disappointment over the results but emphasized the company’s commitment to thoroughly review the data and decide on subsequent steps. He extended gratitude to the participants, their families, healthcare professionals, and the Eyenovia team for their dedication to the trial.

In response to these findings, Eyenovia plans to discontinue the CHAPERONE study. The company intends to analyze the full data set comprehensively before determining its future course of action. This could include various strategic options such as business combinations, reverse mergers, asset sales, or other alternatives to maximize value for stakeholders and reduce expenses.

Eyenovia is renowned for its Optejet platform, which is designed for the treatment of chronic front-of-the-eye diseases. The Optejet dispensing system is praised for its user-friendliness, enhanced safety profile, and potential to improve patient compliance. The company's current commercial product lineup includes clobetasol propionate ophthalmic suspension for post-surgical pain and inflammation, and Mydcombi® for mydriasis. Additionally, Eyenovia has secured licensing and development agreements for its platform to potentially address other significant conditions such as dry eye.

Eyenovia's mission is to leverage its innovative Optejet platform to develop and commercialize ophthalmic products that can significantly improve patient outcomes. The company is continuously exploring new opportunities and partnerships to enhance its product offerings and bring advanced ophthalmic solutions to market.