Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic
biopharmaceutical company developing a pipeline of microdose array
print (MAP™) therapeutics and Arctic Vision, a clinical stage
biotech company focused on developing and commercializing
innovative ophthalmology therapies in China and Asia, today
announced that they have entered into an exclusive license
agreement for Arctic Vision to develop and commercialize MicroPine
for the treatment of progressive myopia and MicroLine for the
treatment of presbyopia in Greater China (mainland China, Hong
Kong, Macau and Taiwan) and South Korea.
Under the terms of the agreement, Eyenovia may
receive up to a total of $45.75 million in upfront payments as well
as additional payments, based on various development and regulatory
milestones, including the initiation of clinical research and
approvals in Greater China and South Korea, and development
costs. In addition, Arctic Vision will purchase its supply of
MicroPine and MicroLine from Eyenovia or, for such products not
supplied by Eyenovia, pay Eyenovia a mid-single digit
percentage royalty on net sales of such products, subject to
certain adjustments. Eyenovia will pay a mid-double digit
percentage of such payments, royalties, or net proceeds of such
supply to its Asian licensee pursuant to the arrangement by
which Eyenovia reacquired rights to such products in Greater China
and South Korea from the original licensee.
“This licensing agreement with Arctic Vision
grows our commercial reach to address some of the largest
progressive myopia markets in the world,” commented Dr. Sean
Ianchulev, Eyenovia’s Chief Executive Officer and Chief Medical
Officer. "With the continued validation of our therapeutic
approach, the agreement also provides non-dilutive capital to
further support our planned launch of MicroStat in the United
States next year, as well as the ongoing development of our late
stage ophthalmology pipeline including MicroPine for progressive
myopia and MicroLine for improvement in near vision.”
Eddy (Hoi Ti) Wu, Ph.D., Founder and CEO, Arctic
Vision added, “Eyenovia is a leader in the field of novel
microdosing technology to treat myopia and presbyopia and we are
committed to accelerating the development of MicroPine and
MicroLine in Greater China and South Korea. In Asia, it is
estimated that up to 50% of children in some regions are myopic,
and the figure is increasing. On the other end of the spectrum,
many people over the age of 40 are gradually suffering from age
related presbyopia, which is currently corrected exclusively with
medical devices or surgery-based modalities. We believe MicroPine
and MicroLine have the potential to address the needs unmet by
conventional eye drops and can play an important role in growing
Arctic Vision’s innovative pipeline. Through this new partnership,
we believe we can lead the Chinese ophthalmology market into the
future.”
About MicroPine for Progressive
MyopiaMicroPine (atropine ophthalmic solution) is for
progressive myopia, a back-of-the-eye condition commonly known as
nearsightedness. Progressive myopia is estimated to affect close to
5 million children in the United States who suffer from
uncontrolled axial elongation of the sclera leading to increasing
levels of myopia and in some cases major pathologic changes such as
retinal atrophy, macular staphylomas, retinal detachment and visual
impairment. MicroPine has been developed for comfort and
ease-of-use in children. Microdose administration of MicroPine is
anticipated to result in low systemic and ocular drug exposure. A
recent therapeutic evidence assessment and review by the American
Academy of Ophthalmology indicates Level 1 (highest) evidence of
efficacy for the role of low dose atropine for progressive myopia
(Ophthalmology 2017;124:1857-1866; Ophthalmology 2016; 123(2)
391:399).
Feasibility Dose-finding Atropine Studies: ATOM
1; ATOM 2; LAMP (Independent Collaborative Group Trials)
About MicroLine for
PresbyopiaMicroLine is a pharmacologic treatment for
presbyopia. Presbyopia is the non-preventable, age related
hardening of the lens, which causes a gradual loss of the eye’s
ability to focus on nearby objects and is estimated to affect
nearly 113 million Americans. Current treatment options are
typically device-based, such as reading glasses and contact lenses.
Pilocarpine ophthalmic solution is known to constrict the pupil and
improve near-distance vision by creating an extended depth of focus
through its small aperture effect. Eyenovia believes that its
administration of pilocarpine using the company’s high precision
microdosing technology could provide a meaningful improvement in
near vision while enhancing tolerability and usability.
About Optejet® and MicroRx Ocular
TherapeuticsEyenovia's Optejet microdose formulation and
delivery platform for ocular therapeutics uses high-precision
piezo-print technology to deliver 6-8 μL of drug, consistent with
the capacity of the tear film of the eye. We believe the volume of
ophthalmic solution administered with the Optejet is less than 75%
of that delivered using conventional eyedroppers, thus reducing
overdosing and exposure to drug and preservatives. Eyenovia's
patented microfluidic ejection technology is designed for fast and
gentle ocular surface delivery, where solution is dispensed to the
ocular surface in approximately 80 milliseconds, beating the ocular
blink reflex. Successful use of the Optejet has been demonstrated
more than 85% of the time after basic training in a variety of
clinical settings compared to 40 – 50% with conventional
eyedroppers. Additionally, its smart electronics and mobile
e-health technology are designed to track and enhance patient
compliance.
About EyenoviaEyenovia, Inc.
(NASDAQ: EYEN) is a clinical stage ophthalmic biopharmaceutical
company developing a pipeline of microdose array print (MAP™)
therapeutics. Eyenovia’s pipeline is currently focused on the
late-stage development of microdosed medications for presbyopia,
myopia progression and mydriasis. For more Information, please
visit www.eyenovia.com.
About Arctic VisionArctic
Vision is a China-based clinical stage specialty ophthalmology
company with a leading portfolio of breakthrough technologies. The
company’s vision is to address ophthalmology’s unmet needs through
innovative therapies in China, Asia and globally. Arctic Vision is
established by top-tier life sciences investors, and led by an
elite team of ophthalmic industry veterans with substantial and
compelling China and global experiences in R&D and
commercialization of eye care products. For more information,
please visit www.arcticvision.com.
Forward Looking
StatementsExcept for historical information, all of 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 in
the United States for our product candidates. 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 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 SEC. In addition,
such statements could be affected by risks and uncertainties
related to, among other things: our ability to timely develop,
implement and maintain manufacturing, commercialization and
marketing capabilities and strategies for our product candidates;
our estimates regarding the potential market opportunity for our
product candidates; the potential advantages of our product
candidates; the rate and degree of market acceptance and clinical
utility of our product candidates; impacts of and uncertainty
related to COVID-19; fluctuations in our financial results,
particularly given market conditions and the potential economic
impact of COVID-19; our need to raise additional money to fund our
operations for at least the next 12 months as a going concern; the
potential impacts of COVID-19 on our supply chain; risks of our
clinical trials, including, but not limited to, the costs, design,
initiation and enrollment (which could still be adversely impacted
by COVID-19 and resulting social distancing), timing, progress and
results of such trials; the timing and our ability to submit
applications for, obtain and maintain regulatory approvals for our
product candidates; the potential success of our reprioritized
pipeline; any cost savings related to our reprioritized pipeline;
our ability to attract and retain key personnel; intellectual
property risks; changes in legal, regulatory and legislative
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 position. 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, we do
not undertake any obligation to update any forward-looking
statements.
Eyenovia Contact:Eyenovia,
Inc.John GandolfoChief Financial Officerjgandolfo@eyenovia.com
Eyenovia Investor Contact:The
Ruth GroupAlexander LoboPhone:
646-536-7037alobo@theruthgroup.com
Eyenovia Media Contact:Pazanga
Health CommunicationsDiana SolteszPhone:
818-618-5634dsoltesz@pazangahealth.com
Arctic Vision Contact:Ms. Chris
FangSenior Director, Corporate Development & Investor
Relationschrisfang@arcticvision.com /
communications@arcticvision.com
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