Eyenovia experienced a significant drop in its stock price after its Phase III CHAPERONE trial, designed to evaluate a drug-device combination for treating pediatric progressive myopia, failed to achieve its primary endpoint. The company's stock price decreased by over two-thirds, falling from $0.34 per share on November 14 to $0.10 at the close of the market on November 15.
The CHAPERONE trial (NCT03942419) investigated the efficacy of Eyenovia's combination of low-dose atropine, administered through its Optejet dispensing platform, as a potential treatment for pediatric progressive myopia. The primary endpoint was defined as a less than 0.5 diopter progression in visual acuity over a three-year period. Data from the 252-patient study revealed that there was no statistically significant difference in the rate of myopia progression between the experimental and active comparator arms. According to the company, all dosages and the placebo were well-tolerated, with only mild and infrequent adverse events reported during the trial.
"We are disappointed that the DRC determined that the CHAPERONE study does not appear to be meeting its primary efficacy endpoint," stated Eyenovia CEO Michael Rowe. "We plan to terminate the study, review the data more thoroughly, and evaluate the next steps."
Eyenovia has indicated that it is now evaluating its strategic options, including the possibility of a business combination, reverse merger, asset sales, or a combination of these alternatives, with the goal of preserving company value. The Optejet medication dispensing platform is designed to address front-of-the-eye diseases, offering an easy-to-use treatment option for conditions like myopia. The National Institutes of Health (NIH) estimates that myopia affects approximately 41.6% of Americans.
Competitive Landscape in Myopia Treatment
While Eyenovia faces challenges, other companies in the myopia treatment field are making progress. Vyluma recently announced positive top-line data from the second stage of its Phase III Childhood Atropine for Myopia Progression (CHAMP) clinical study. Additionally, the FDA has approved Johnson & Johnson Vision’s ACUVUE Ability Overnight Therapeutic Lenses for managing myopia.
