Eyenovia’s stock craters to its lowest point in its six-year lifespan as a public company following the biotech’s termination of its lead program in pediatric progressive myopia due to lack of efficacy.
This year has been the best of times and the worst of times for Eyenovia, which notched an FDA approval in March but saw its already depressed stock plummet to less than 10 cents Friday after announcing it would discontinue a late-stage study in pediatric progressive myopia.
The New York–based biotech made the decision after a review by an independent Data Review Committee (DRC) determined that its drug-device combination of low-dose atropine was not meeting the primary endpoint in the Phase III CHAPERONE study. After reviewing safety and efficacy data from 252 evaluable patients, the DRC found that the rate of myopia progression was not significantly different between the two active treatment arms and placebo, according to Friday’s press release.
The candidate, dubbed MicroPine, is Eyenovia’s lead investigational candidate. The company also has three assets in Phase II development for dry eye disease.
Eyenovia’s shares were down around 70% at market open Friday following the announcement.
In an investor note Friday, William Blair downgraded the company to “Market perform” based on the negative results from CHAPERONE and what it called the company’s capital constraints.
“We are disappointed that the DRC determined that the CHAPERONE study does not appear to be meeting its primary efficacy endpoint,” Eyenovia CEO Michael Rowe said in a statement, adding that the company plans to review the data more thoroughly and evaluate next steps.
Eyenovia has two marketed products, including clobetasol propionate 0.05% eye drops, approved in March 2024 to treat post-operative inflammation and pain after eye surgery. Developed with Taiwan-based partner Formosa Pharmaceuticals, the solution was the first FDA-approved ophthalmic clobetasol propionate drug and the first steroid to enter the ophthalmic space in more than 15 years.
In a statement at the time, Rowe said that given its more favorable dosing and profile compared to other post-surgical steroid options, Eyenovia believes the drug has “has the potential to capture a significant share of an estimated $1.3 billion annual market opportunity.”
Eyenovia also markets MydCombi for mydriasis, which it describes on its website as the first and only FDA-approved fixed dose combination ophthalmic spray for pupil dilation.
“While we still see value in the company’s pipeline and commercial products, especially the launch of clobetasol propionate ophthalmic solution 0.05%, with only $7.2 million in cash at the end of the third quarter and no clear path on which to raise additional capital (at least on favorable terms), we believe its ability to invest in the launch and realize the potential value of clobetasol is limited,” William Blair wrote in its note.
