Eyenovia Inc. (EYEN) experienced a significant drop in its stock price following the announcement that its Phase III CHAPERONE trial failed to meet its primary endpoint. The study, designed to evaluate the efficacy of a low-dose atropine formulation delivered via Eyenovia's Optejet dispensing platform for the treatment of pediatric progressive myopia, did not demonstrate a statistically significant difference in myopia progression compared to the active comparator arm.
The CHAPERONE trial (NCT03942419) enrolled 252 patients and aimed to show a less than 0.5 diopter progression in visual acuity over three years. However, data indicated that the rate of myopia progression was not significantly different between the experimental and control groups. While the company reported that all dosages and the placebo were well-tolerated, with only mild and infrequent adverse events, the lack of efficacy led to the trial's termination.
"We are disappointed that the DRC determined that the CHAPERONE study does not appear to be meeting its primary efficacy endpoint," said Michael Rowe, Eyenovia's chief executive officer. "We plan to terminate the study, review the data more thoroughly, and evaluate the next steps."
Strategic Options Under Consideration
Faced with the trial's failure, Eyenovia is now weighing its strategic options. The company has indicated that it may consider a potential business combination, reverse merger, asset sales, or a combination of these alternatives in an effort to preserve company value. The company's Optejet platform was intended to address front-of-the-eye diseases, including myopia, which the NIH estimates affects around 41.6% of Americans.
Myopia Treatment Landscape
The myopia treatment field has seen recent activity from other companies. Vyluma reported positive top-line data from the second stage of its Phase III Childhood Atropine for Myopia Progression (CHAMP) clinical study. Additionally, the FDA recently approved Johnson & Johnson Vision’s ACUVUE Abilitiy Overnight Therapeutic Lenses for managing myopia.
