Eyenovia re-acquires development, commercialization rights to MicroPine in US, Canada

(Image Credit: AdobeStock/Monster Ztudio)

Eyenovia Inc announced it has re-acquired the rights to MicroPine in the United States and Canada.

According to a news release, MicroPine, an investigational 8-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 noted in its news release it estimates that more than 25 million children in the United States suffer from myopia, and, of these, 5 million are believed to be at high risk for progressive myopia.

Progressive myopia, if left unchecked, has the potential to 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.

Michael Rowe, CEO of Eyenovia, noted in the news release that with the FDA approval of MydCombi for in-office mydriasis (pupil dilation), together with the company’s recent announcement that we in-licensed the U.S. commercial rights to APP13007 for post-ocular surgical pain and inflammation from Formosa Pharmaceuticals, its 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,” Rowe said.

“MicroPine would also utilize our Optejet dispensing technology, which is highly differentiated and confers significant advantages to eye doctors and patients as compared to traditional eye drops, including less systemic exposure, better compliance among children, ease of use, and potentially better local tolerability,” Rowe added.

Moreover, Rowe noted the re-acquisition of the rights to MicroPine in the U.S. and Canada is consistent with the company’s broader corporate strategy to expedite commercialization of advanced products using the Optejet.

“We believe we are ideally positioned to complete remaining development steps in an expedited and capital efficient manner, and, to that end, we plan to meet with the FDA early this year to align on a path forward for this high-value program,” Rowe concluded.

In connection with this transaction, Eyenovia will pay Bausch + Lomb Ireland Limited an upfront payment consisting of $2 million in cash and $3 million in shares of common stock, as well as a low single-digit royalty on Eyenovia’s net sales of MicroPine in the United States and Canada.

This agreement has no impact on Eyenovia’s ongoing partnership with Arctic Vision, which covers development of MicroPine (as well as Mydcombi and MicroLine/Apersure) for Greater China and South Korea.

In August 2023, Eyenovia acquired the U.S. commercial rights to APP-13007 (clobetasol propionate ophthalmic nanosuspension 0.05%) from Formosa Pharmaceuticals. APP-13007, which currently is under review by the FDA, is a potent steroid being developed to reduce pain and inflammation after ocular surgery.

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of March 4 for APP-13007.