NEW YORK - Eyenovia, Inc. (NASDAQ: NASDAQ:EYEN), a commercial-stage ophthalmic company, has announced its intention to explore strategic alternatives to enhance shareholder value, including the potential sale of the company or its assets, a merger, or other strategic actions.
This announcement comes as the company focuses on advancing its ophthalmic products, including MicroPine for pediatric progressive myopia, which lacks FDA-approved pharmaceutical treatments and represents a significant market opportunity in the United States and China.
The company is preparing for an interim analysis of its CHAPERONE study data for MicroPine later this year, with the possibility of filing a New Drug Application (NDA) with the FDA in 2025. Eyenovia's CEO, Michael Rowe, expressed optimism about the upcoming analysis and the company's commercialization strategy, which includes the already marketed Mydcombi for mydriasis and the upcoming launch of clobetasol propionate ophthalmic suspension 0.05% for post-surgical pain and inflammation management.
Eyenovia is also preparing to propose a fast-track approval path for its next-generation Optejet device to the FDA. The device is optimized for home use and offers manufacturing advantages, potentially supporting the company's current programs and fostering new partnerships.
Despite these developments, Rowe acknowledged that the financial markets might have underrecognized the potential of MicroPine and the company's progress. As a result, Eyenovia is taking steps to reduce operating expenses without impacting its core strategy while exploring transactions that could generate capital or otherwise enhance shareholder value.
The pediatric progressive myopia market is estimated to be worth $1.8 billion, with about five million children at high risk of significant vision loss in the U.S. alone. Eyenovia's engagement with investment banks will assist in evaluating potential strategic options, though there is no guarantee that this process will result in any transaction.
The company has made this announcement to keep shareholders and the public informed and does not plan to disclose further details about the strategic review process unless a specific action is approved. The information in this article is based on a press release statement.
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