Full Press Release Details
Eyenovia Re-Acquires Development and Commercialization
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- January 16, 2024-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:
"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.
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.
PLEASE GO TO MYDCOMBI.COM FOR IMPORTANT
SAFETY INFORMATION for MYDCOMBI (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5%
About Eyenovia, Inc.
Eyenovia, Inc. (NASDAQ:
EYEN) is a commercial-stage ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics based
on its Optejet platform. Eyenovia is currently focused on the commercialization of Mydcombi (tropicamide+phenylephrine ophthalmic spray)
In addition to commercializing Mydcombi, in August
2023, Eyenovia acquired the U.S. commercial rights to APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%) from Formosa Pharmaceuticals.
APP13007, which is currently under review by the FDA, is a potent steroid being developed to reduce pain and inflammation following ocular
surgery. The agency has assigned a Prescription Drug User Fee Act (PDUFA) action date for APP13007 of March 4, 2024.
Eyenovia is also advancing
late-stage development of medications in the Optejet device for presbyopia and myopia progression (partnered with Arctic Vision in China
For more information,
The Eyenovia Corporate Information slide
deck may be found at ir.eyenovia.com/events-and-presentations.
Forward-Looking Statements
Except for historical information, all the statements,
expectations and assumptions contained in this press release are forward-looking statements. Forward-looking statements include, but are
not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating
to our future activities or other future events or conditions, including estimated market opportunities for our product candidates and
platform technology, and the potential for approval of APP13007. These statements are based on current expectations, estimates and projections
about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve
risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and in some cases are
likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors discussed
from time to time in documents which we file with the U.S. Securities and Exchange Commission.
In addition, such statements could be affected
by risks and uncertainties related to, among other things: risks of our clinical trials, including, but not limited to, the costs, design,
initiation and enrollment, timing, progress and results of such trials; the timing of, and our ability to submit applications for, obtaining
and maintaining regulatory approvals for our product candidates; the potential advantages of our product candidates and platform technology;
the rate and degree of market acceptance and clinical utility of our product candidates; our estimates regarding the potential market
opportunity for our product candidates; reliance on third parties to develop and commercialize our product candidates; the ability of
us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies
for our product candidates; intellectual property risks; changes in legal, regulatory, legislative and geopolitical environments in the
markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products; and our competitive
Any forward-looking statements speak only as of
the date on which they are made, and except as may be required under applicable securities laws, Eyenovia does not undertake
any obligation to update any forward-looking statements.
Chief Financial Officer
Eyenovia Investor Contact:
LifeSci Advisors, LLC
Eyenovia Media Contact:
Vice President, Commercial Operations