Eyenovia Announces Updated Strategy and Corporate Priorities to Focus on Shareholder Value Generation and Immediate Commercial Opportunities

• Company focusing on multi-billion dollar opportunity in pediatric progressive myopia represented by MicroPine, with interim analysis planned for 4Q 2024 and a potential NDA to the FDA in 2025
  
• Continuing to advance commercialization of Mydcombi for mydriasis and preparing to launch clobetasol propionate ophthalmic suspension 0.05% for post-surgical management of pain and inflammation; both represent large multi-million-dollar opportunities
  
• Company exploring wide range of strategic alternatives
  

NEW YORK, April 08, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company, today announced its plans for accelerating development of its potential multi-billion 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 potential sale of assets of the Company, a sale of the Company, a merger, or other strategic action. 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. 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 towards an NDA filing in 2025,” stated Michael Rowe, Eyenovia’s Chief Executive Officer.