Eyenovia (NASDAQ: EYEN) has announced that its Phase 3 CHAPERONE study, which was evaluating low-dose atropine using the Optejet platform for the treatment of pediatric progressive myopia, did not meet its primary endpoint. The independent Data Review Committee (DRC) found no statistically significant difference in myopia progression between the treatment arms (0.01% and 0.1% atropine) and the placebo group among the 252 evaluable patients.
The primary endpoint of the study was to demonstrate less than 0.5 diopter progression in visual acuity over a three-year period. While the safety analysis indicated that all dosages were well-tolerated with a mild and infrequent adverse event profile, the lack of efficacy has led the company to terminate the study and consider strategic alternatives.
Details from the CHAPERONE Study
The Phase 3 CHAPERONE study was designed to assess the efficacy and safety of low-dose atropine administered via Eyenovia's Optejet platform in children with progressive myopia. The trial enrolled 252 evaluable patients, who were randomized to receive either 0.01% atropine, 0.1% atropine, or a placebo. The primary outcome measure was the change in visual acuity over three years, with a target of less than 0.5 diopter progression.
According to the announcement, the DRC's review of the data revealed that there was no significant difference in the rate of myopia progression between the two active treatment arms and the placebo group. However, the safety analysis showed that all dosages and the placebo were well-tolerated, with only mild and infrequent adverse events reported.
Strategic Implications for Eyenovia
Michael Rowe, Chief Executive Officer of Eyenovia, expressed disappointment with the study's outcome. In light of these results, the company is now considering various steps to maximize value for stakeholders, reduce expenses, and evaluate strategic options. These options may include a business combination, reverse merger, asset sales, or a combination of these alternatives.
The failure of the CHAPERONE study represents a setback for Eyenovia's pediatric myopia program. The company's shift towards exploring strategic alternatives suggests concerns about its future direction and financial stability. Investors are advised to monitor Eyenovia's cash position and burn rate closely, as pipeline setbacks often lead to increased financing needs under potentially unfavorable terms.
