Eyenovia Stock Tumbles on Termination of Phase III Myopia Study

Core Viewpoint - Eyenovia, Inc. has decided to terminate the phase III study of its investigational drug-device product, MicroPine, for pediatric progressive myopia after an independent Data Review Committee concluded it was unlikely to meet its primary endpoint [1][2][4]. Company Developments - The Data Review Committee evaluated safety and efficacy data from 252 patients and found no significant difference in myopia progression between treatment groups and placebo [3]. - Following the DRC's feedback, Eyenovia is conducting a thorough review of the study data to determine next steps [4]. - The company's stock plummeted 70% after the announcement, with a year-to-date decline of 95.1%, compared to the industry's 10.5% decline [4]. Marketed Portfolio - Eyenovia currently has two FDA-approved products: Mydcombi and clobetasol propionate, which are yet to gain significant market traction [5]. - Mydcombi was approved in May 2023 and launched in August 2023, while clobetasol propionate received FDA approval in March 2024 and was launched in Q3 2024 [6]. Clinical Pipeline - Besides MicroPine, Eyenovia has other candidates in mid-stage development targeting various dry eye indications [7]. Strategic Options - The company is exploring ways to maximize stakeholder value, which may include cost-cutting measures, business combinations, reverse mergers, or asset sales [4].