Eyenovia, Inc. announced on November 15, 2024, that it would terminate its late-stage CHAPERONE study for MicroPine, an experimental drug-device combination for pediatric progressive myopia. An independent Data Review Committee found the trial did not meet its primary three-year efficacy endpoint.
The primary endpoint was defined as a less than 0.5 diopter progression in visual acuity over three years. The committee reviewed safety and efficacy data from 252 evaluable patients and determined that the rate of myopia progression was not significantly different between the two active treatment arms (0.01% and 0.1% atropine) and placebo.
In light of these negative results, Eyenovia plans to terminate the study, conduct a thorough review of the data, and evaluate next steps for the program. The company is considering a variety of strategic options, including a business combination, reverse merger, or asset sales, to maximize stakeholder value and reduce expenses.
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