Eyenovia Stock Sinks As Pivotal Trial Fails To Hit Primary Efficacy Goal, Analyst Downgrades Due To Limited Capital And Near Term Upside From Pipeline

On Friday, Eyenovia, Inc. EYEN stock is trading lower after an update from the Phase 3 CHAPERONE study evaluating its proprietary drug-device combination of low-dose atropine in the company’s Optejet dispensing platform pediatric progressive myopia.

Progressive myopia is a type of nearsightedness that worsens over time due to the eyeball growing too long.

The company said that an independent Data Review Committee (DRC) reviewed the CHAPERONE data and found that the trial is not meeting its primary endpoint of a less than 0.5 diopter progression in visual acuity over three years.

The DRC reviewed the 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 (0.01% and 0.1% atropine ophthalmic metered spray) and placebo.

In the safety analysis, all dosages and placebo appeared well-tolerated, with a mild and infrequent adverse event profile. Full study data has not yet been released to Eyenovia.

“We plan to terminate the study, review the data more thoroughly, and evaluate the next steps,” stated Michael Rowe, Eyenovia’s CEO.

In light of the results of this review, the company is considering strategic options, which may include a business combination, reverse merger, asset sales or a combination of those alternatives.

William Blair has downgraded Eyenovia to Market Perform.

The analyst says,” While the approval of Mydcombi provided important validation of Eyenovia's Optejet device, and the subsequent approval of clobetasol propionate ophthalmic solution 0.05% added another promising product to the company's commercial portfolio, we believe the negative results from the CHAPERONE study and limited capital to invest in the launch of clobetasol or further pipeline programs limits near-term upside.”

Price Action: EYEN stock is down 68.2% at $0.1083 at last check Friday.

Image via Unsplash

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