Myopia Eye Drop Phase III Study Fails, Ophthalmology Company Shares Drop 70%

On November 15, ophthalmology company Eyenovia announced in a press release that, following an evaluation by an independent Data Review Committee (DRC), the Phase III CHAPERONE study of MicroPine (a low-dose atropine formulation for delaying myopia progression in children) failed to meet its primary endpoint (less than 0.5 diopters of visual progression within 3 years).

After the news was released, Eyenovia's stock price dropped by 70%.

MicroPine is a low-dose spray containing either 0.1% or 0.01% atropine, developed by Eyenovia based on its ophthalmic drug delivery platform, Optejet. Eyenovia had high hopes for the product, believing its peak sales could exceed $1 billion.

The CHAPERONE study is a multicenter, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of MicroPine compared to a placebo for delaying the progression of myopia in children. 

The DRC reviewed the safety and efficacy data from 252 evaluable patients. The results showed no significant difference in myopia progression between the two concentrations of MicroPine and the placebo group. In the safety analysis, all doses of MicroPine, as well as the placebo, appeared to have good tolerability, with mild and infrequent adverse events.

Eyenovia CEO Michael Rowe stated, "We are disappointed that the DRC determined the CHAPERONE study did not appear to meet its primary efficacy endpoint. We plan to terminate the study and conduct a more thorough review of the existing data, after which we will assess next steps." 

In light of the results of this review, Eyenovia is considering taking various actions to maximize stakeholder value, reduce expenses, and evaluate its strategic options, which may include business mergers, reverse mergers, asset sales, or combinations of these alternatives.