January 18, 2024
NEW YORK — Eyenovia has regained the rights to MicroPine, an investigational eight microliter ophthalmic spray of atropine delivered by Eyenovia’s proprietary Optejet device, in the United States and Canada. MicroPine is being evaluated as a potential treatment for pediatric progressive myopia.
The re-acquisition of MicroPine 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.
- This will expand 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.”
“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. Our re-acquisition of the rights to MicroPine in the U.S. and Canada is consistent with our 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,” Mr. 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.