Eyenovia's stock price plummeted after the company announced the discontinuation of its Phase III CHAPERONE study evaluating MicroPine, a drug-device combination of low-dose atropine for pediatric progressive myopia. The decision followed a review by an independent Data Review Committee (DRC), which determined that the study did not meet its primary endpoint.
CHAPERONE Study Fails to Meet Primary Endpoint
The Phase III CHAPERONE study included 252 evaluable patients. The DRC's review of the safety and efficacy data revealed that the rate of myopia progression was not significantly different between the two active treatment arms and the placebo group. This outcome led Eyenovia to halt the development of MicroPine, its lead investigational candidate.
According to Eyenovia CEO Michael Rowe, the company is disappointed with the DRC's determination and plans to conduct a more thorough review of the data to evaluate the next steps. The failure of the CHAPERONE study represents a significant setback for Eyenovia, particularly given MicroPine's status as the company's primary focus.
Stock Plunge and Financial Implications
Following the announcement, Eyenovia's shares experienced a dramatic drop of approximately 70%. William Blair downgraded the company to "Market perform," citing the negative results from the CHAPERONE study and concerns about Eyenovia's capital constraints. The firm noted that Eyenovia had $7.2 million in cash at the end of the third quarter and faces uncertainty in raising additional capital on favorable terms.
Focus on Marketed Products
Despite the setback with MicroPine, Eyenovia has two marketed products. One is clobetasol propionate ophthalmic solution 0.05%, approved in March 2024 for treating post-operative inflammation and pain after eye surgery. Developed in partnership with Formosa Pharmaceuticals, this solution is the first FDA-approved ophthalmic clobetasol propionate drug and the first steroid to enter the ophthalmic space in over 15 years.
Eyenovia also markets MydCombi, the first and only FDA-approved fixed-dose combination ophthalmic spray for pupil dilation. William Blair acknowledged the value in Eyenovia's pipeline and commercial products, particularly the launch of clobetasol propionate ophthalmic solution 0.05%. However, they also cautioned that the company's limited cash reserves could restrict its ability to invest in the launch and fully realize the product's potential, which is estimated to be a $1.3 billion annual market opportunity.
