NEW YORK—Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company, announced its plans for accelerating development of its potential multibillion dollar product for pediatric progressive myopia (MicroPine) and initiated a process to explore strategic alternatives to maximize shareholder value. As part of this process, the company plans to consider a wide range of options, including a potential sale of assets of the company, a sale of the company, a merger or other strategic action, the company said.

In conjunction with the strategic process and focus on its late stage MicroPine asset, Eyenovia reiterated its immediate commercialization opportunities and corporate savings intended to reduce operating expenses while continuing to support meaningful value generation from the company's two FDA-approved products.

“The pediatric progressive myopia market represents a significant opportunity for Eyenovia both in the United States and China,” said Michael Rowe, Eyenovia’s chief executive officer. “This disease, for which there are no FDA-approved pharmaceutical treatments, has been called an epidemic by several medical and optometric organizations. The sheer number of children at high risk of developing significant, permanent vision loss due to progressive myopia is estimated to be five million in the U.S., and the value of this indication has been estimated to be $1.8 billion by third-party experts in the field.

"We are excited by the prospect of an interim analysis of our Chaperone data later this year, when we can evaluate whether or not this placebo-controlled study should continue as is or potentially move rapidly toward an NDA filing in 2025.” 

He continued, “In the meantime, we will be evaluating strategic opportunities for MicroPine with organizations that have existing capabilities and infrastructure necessary to fully capitalize on this large opportunity. Additionally, we continue to make significant progress advancing our commercialization strategy, with Mydcombi and Avenova currently being sold through our targeted sales force, and clobetasol to be commercially launched as soon as this summer.

“We are also preparing to meet with the FDA over the summer to propose a fast path forward for approval of our next generation Optejet device, which, given its optimization for home use and significant manufacturing advantages relative to our current version, not only better positions us to support our current programs and partnerships, but new potential collaborations as well.

“However, we believe this progress, and the broader potential of MicroPine, which will be back in our hands in a matter of weeks, has been underrecognized and underappreciated by the financial markets. As a result, while we remain intently focused on laying a foundation for accelerating sales growth in 2025, we are in parallel reducing costs in areas that do not impact our ability to deliver on our core strategy and exploring a possible transaction or transactions that could generate capital or otherwise enhance value for our shareholders, who remain very supportive. I look forward to evaluating a comprehensive variety of alternatives with my fellow board members in the coming weeks.”

Eyenovia is making this announcement to inform shareholders and the public that in addition to the active execution of the company’s ophthalmic programs outlined in its corporate presentation and regulatory filings, the company also plans to engage in discussions for strategic alternatives with the goal of maximizing value for shareholders. Eyenovia is in the process of engaging with investment banks to assist with the evaluation, the company said.