Eyenovia Re-Acquires Development and Commercialization Rights to MicroPine in the U.S. and Canada

MicroPine, currently in late phase III for pediatric progressive myopia, to complement Eyenovia’s commercial-stage asset, Mydcombi, as well as its pre-PDUFA candidate, APP13007

Part of corporate strategy to expedite commercialization of advanced products using the Optejet device

Market estimated to be nearly $2 billion annually in the U.S. by Review of Myopia Management

NEW YORK, Jan. 16, 2024 (GLOBE NEWSWIRE) --  Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage, ophthalmic company, today announced that it has re-acquired the rights to MicroPine in the U.S. and Canada.

MicroPine, an investigational eight microliter ophthalmic spray of atropine delivered by Eyenovia’s proprietary Optejet device, is being evaluated as a potential treatment for pediatric progressive myopia (worsening near-sightedness), which is characterized by elongation of the sclera/retina. Eyenovia estimates that more than 25 million children in the U.S. suffer from myopia, and, of these, five million are believed to be at high risk for progressive myopia. If left untreated, progressive myopia can ultimately lead to significant vision loss and potential blindness. Prior studies have demonstrated that atropine can slow myopia progression by as much as 60%, and there is a significant unmet need for safe and effective FDA-approved treatment options.

The re-acquisition of MicroPine greatly expands Eyenovia’s phase III pipeline and commercial opportunities, as follows:

• As Eyenovia accelerates its commercial capabilities in 2024 with the expanded launch of MydCombi and the anticipated introduction of APP-13007 (pending FDA approval anticipated in March), MicroPine adds a major late-stage asset in a large market with high unmet medical need;
• Based upon the Company’s internal forecast, by acquiring back the MicroPine rights, the overall asset value of the MicroPine program to Eyenovia more than doubles compared to what the Company would have been eligible to receive under the original license agreement;
• Eyenovia will work to accelerate the ongoing CHAPERONE phase III trial and engage with FDA to explore options to expedite development and registration of MicroPine;
• Expands the territories in which the CHAPERONE study may be conducted to support registration as well as the field of potential collaborators to engage for future partnering or strategic discussions.

“With the FDA approval of MydCombi for in-office mydriasis (pupil dilation), together with our recent announcement that we in-licensed the U.S. commercial rights to APP13007 for post-ocular surgical pain and inflammation from Formosa Pharmaceuticals, our commercialization strategy is accelerating,” stated Michael Rowe, chief executive officer of Eyenovia. “We believe the addition of MicroPine, if approved, would be highly complementary to these products.”