Eyenovia Stock Dives 70% Following the Termination of Its Lead Program

Eyenovia Stock Dives 70% Following the Termination of Its Lead Program

Eyenovia Stock Dives 70% Following the Termination of Its Lead Program

This year has presented both triumphs and challenges for Eyenovia. The biotech firm, based in New York, received FDA approval in March. However, following the announcement of its cessation of a late-stage study in pediatric progressive myopia, the company’s already struggling stock fell below 10 cents on Friday.

The decision to halt the study was made after an assessment by an independent Data Review Committee (DRC), which concluded that Eyenovia’s drug-device combination using low-dose atropine failed to meet the primary endpoint of the Phase III CHAPERONE trial. The DRC reviewed data from 252 evaluable patients and determined that the progression of myopia did not differ significantly between the placebo group and the two active treatment arms, as outlined in Friday’s press release.

Eyenovia’s leading investigational candidate, MicroPine, is vital for the company, which also has three products in Phase II trials targeting dry eye disease.

Upon the announcement, Eyenovia shares registered a decline of approximately 70% during market opening hours on Friday.

In a note to investors, William Blair downgraded the company to “Market perform,” referring to the unfavorable results from the CHAPERONE study and the company’s existing financial constraints.

“We express our disappointment regarding the DRC’s conclusion that the CHAPERONE study did not meet its primary efficacy measure,” said Eyenovia CEO Michael Rowe, mentioning that the company intends to conduct a deeper analysis of the data and explore future strategies.

Eyenovia’s portfolio includes two marketed products, among which is clobetasol propionate 0.05% eye drops, approved in March 2024 for managing postoperative inflammation and pain following eye surgeries. This product was jointly developed with Formosa Pharmaceuticals, marking it as the first FDA-approved ophthalmic clobetasol propionate medication and the first new steroid in over 15 years for the ophthalmic market.

Rowe previously stated that, due to its favorable dosing profile compared to existing post-surgical steroid alternatives, the drug possesses “the potential to capture a significant share of a projected .3 billion annual market opportunity.”

Additionally, Eyenovia offers MydCombi for mydriasis, which it promotes as the first and only FDA-approved fixed dose combination ophthalmic spray designed for pupil dilation, as detailed on its website.

“Although we still regard the company’s pipeline and commercial offerings positively, particularly with the launch of clobetasol propionate ophthalmic solution 0.05%, the indication that cash reserves stood at only .2 million at the conclusion of the third quarter, without a specified strategy for raising additional funds (at least on favorable terms), limits the company’s ability to adequately invest in the product launch and maximize the potential of clobetasol,” noted William Blair in their report.