Eyenovia Discontinues Phase 3 CHAPERONE Study After Review

Eyenovia's CHAPERONE Study Update

An independent Data Review Committee has reviewed the data from Eyenovia's Phase 3 CHAPERONE study, determining that the trial is not achieving its primary three-year efficacy endpoint. This news comes as a disappointment, especially since Eyenovia, Inc. (NASDAQ: EYEN), a leading ophthalmic technology company, was evaluating its low-dose atropine drug-device combination.

Independent Data Review Committee Findings

The evaluation conducted by the Data Review Committee (DRC) involved 252 patients who were monitored for changes in visual acuity over three years. The results indicated that the rate of myopia progression in participants receiving either of the active treatments—0.01% or 0.1% atropine ophthalmic metered spray—was not significantly different from that of the placebo group.

Safety Analysis Results

In terms of safety, all treatment dosages and the placebo demonstrated a good tolerance level among participants. Adverse events were described as mild and infrequent, suggesting that the treatments did not pose significant health risks. However, the full set of study data is still pending release to Eyenovia.

Next Steps for Eyenovia

Following the disappointing outcomes of the DRC's review, Eyenovia plans to discontinue the CHAPERONE study. Michael Rowe, the Chief Executive Officer of Eyenovia, expressed his disappointment and emphasized the company's commitment to a thorough evaluation of the complete dataset before deciding on future steps. Rowe acknowledged the invaluable contributions of the children, parents, caregivers, and healthcare professionals involved in the trial.

Company's Strategic Considerations

In light of these findings, Eyenovia is weighing various strategic alternatives to optimize stakeholder value. Potential pathways being considered include reducing operational expenses and exploring options for business combinations, reverse mergers, or asset sales. Eyenovia will release more details once a comprehensive evaluation of these strategic alternatives is completed.

About Eyenovia, Inc.

Eyenovia, Inc. (NASDAQ: EYEN) specializes in developing and commercializing innovative products focused on chronic front-of-the-eye diseases. Its proprietary Optejet dispensing platform is designed for ease of use, improved safety, and better patient compliance. Currently, the company offers products such as clobetasol propionate ophthalmic suspension for managing post-surgical pain and inflammation, and Mydcombi for mydriasis. Moreover, Eyenovia is pursuing additional indications, including dry eye treatments, leveraging the benefits of its Optejet platform.

Frequently Asked Questions

What is the primary finding from the CHAPERONE study review?

The independent Data Review Committee concluded that the CHAPERONE study is not meeting the primary efficacy endpoint of reducing myopia progression in children over three years.

What actions is Eyenovia planning to take after the study findings?

Eyenovia intends to discontinue the CHAPERONE study and will conduct a thorough review of the data before deciding on future strategies.

How has the safety profile of the treatments in the study been characterized?

The treatments, including the atropine sprays and placebo, were generally well-tolerated, with mild and infrequent adverse events.

What does Eyenovia's Optejet platform focus on?

The Optejet platform aims to deliver a better experience for treating chronic front-of-the-eye diseases, enhancing safety and compliance for patients.

What potential business strategies is Eyenovia considering?

The company is evaluating options that may involve business combinations, reverse mergers, asset sales, or cutting expenses to maximize stakeholder value.

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