Matt Kaplan's questions to EYEN leadership • Q3 2024
Question
Inquired about the statistical power of the CHAPERONE interim analysis, the process following the independent review, the potential timeline for an NDA filing if results are positive, and the ability to leverage existing atropine safety data.
Answer
The study is believed to be adequately powered at around 85%. The independent committee will provide a go/no-go recommendation, after which Eyenovia would unblind and analyze the full data. A positive result could accelerate an NDA filing to the first half of 2026. The FDA already allows leveraging data from the LAMP and ATOM studies, but Eyenovia also believes its own safety data will be superior and important for the label.