Eyenovia Stock Tumbles on Termination of Phase III Myopia Study

Zacks Equity Research

Mon, Nov 18, 2024, 7:49 AM 3 min read

Eyenovia, Inc. EYEN announced the decision to terminate a phase III study evaluating its investigational drug-device product, MicroPine, as a potential treatment for pediatric progressive myopia. MicroPine is EYEN’s proprietary drug-device combination of low-dose atropine administered using the company’s Optejet dispensing platform.

The decision was taken after an independent Data Review Committee (DRC) determined that the phase III CHAPERONE study of MicroPine was unlikely to meet its primary endpoint of less than 0.5 diopter progression in visual acuity over three years.

The DRC evaluated safety and efficacy data from 252 patients and found no significant difference in myopia progression between the two treatment groups (0.01% and 0.1% atropine ophthalmic metered spray) and placebo. However, all doses of the candidate and the placebo were well-tolerated in the CHAPERONE study, with only mild and infrequent adverse events. The complete study data is yet to be provided to Eyenovia.

Based on this DRC feedback, Eyenovia has decided to terminate the phase III CHAPERONE study of MicroPine for the myopia indication. The company is currently gearing up for a thorough review of the study data to evaluate next steps.

The stock plunged 70% on Friday following the news. Year to date, shares of EYEN have plunged 95.1% compared with the industry’s 10.5% decline.

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The company further reported that it is also exploring ways to maximize stakeholder value, cut costs and assess strategic options, which may include a business combination, reverse merger, asset sales, or a combination of these. Additional details will be shared after the evaluation is complete.

EYEN’s Marketed Portfolio of Drugs

The company currently has two FDA-approved products, Mydcombi and clobetasol propionate, which are indicated for in-office pupil dilation and post-ocular inflammation and pain, respectively. Both drugs are yet to gain traction in the market.

Mydcombi received FDA approval in May 2023 for inducing mydriasis for diagnostic procedures and in conditions where short-term pupil dilation is desired. The drug was launched in the U.S. market in August 2023. Clobetasol propionate, on the other hand, was only approved by the FDA in March 2024 and subsequently launched in the United States during the third quarter of 2024.

Apart from MicroPine, Eyenovia’s clinical-stage pipeline comprises a few other candidates that are currently undergoing mid-stage development for various dry eye indications.