Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic
biopharmaceutical company developing a pipeline of microdose
therapeutics utilizing its patented piezo-print delivery
technology, today announced that the Company is advancing the
development of its MicroLine program for the improvement in near
vision in patients with presbyopia towards Phase III development.
As a result of prioritizing MicroLine in tandem with its MicroPine
(progressive myopia) and MicroStat (mydriasis) programs, the
Company is deferring development activities for its MicroProst
(glaucoma and ocular hypertension) and MicroTears (red eye and itch
relief/lubrication) programs.
Presbyopia is a non-preventable, age-related
hardening of the lens, which causes the gradual loss of the eye’s
ability to focus on nearby objects, commonly known as
farsightedness. There are currently no known FDA-approved drugs for
the improvement in near vision in patients with presbyopia and
existing modalities are typically device-based, such as reading
glasses or contact lenses. In the United States, presbyopia affects
an estimated 113 million people, of which Eyenovia estimates that
approximately 43 million people between the ages of 40 and 65 who
have otherwise normal vision could benefit from a pharmacologic
treatment option like MicroLine.
“The MicroLine program, based on our proprietary
piezo-formulation of the well-known drug pilocarpine, could
potentially be one of the first pharmacologic treatment options for
presbyopia. Combined with our novel platform technology, we believe
that Eyenovia can provide people interested in enhancing their
lifestyle with pharmacotherapy similar to other aesthetic-focused
products. MicroLine is designed to replace reading glasses for
approximately 3-4 hours, while addressing the tolerability and
instillation issues associated with traditional eye drop
approaches,” commented Dr. Sean Ianchulev, Eyenovia’s Chief
Executive Officer and Chief Medical Officer. “We anticipate
initiating and completing the Phase III VISION trials for MicroLine
in 2020.”
Dr. Fred Eshelman, Eyenovia’s Chairman of
the Board added, “After conducting a strategic review of Eyenovia’s
pipeline with the goal of maximizing the value of its portfolio, we
believe that MicroLine, MicroPine and MicroStat represent the
highest value opportunities for Eyenovia, with potential product
launches from 2022 to 2024. We believe these three programs focus
on areas with significant unmet needs or where the patient
experience could be greatly improved. MicroLine, in particular,
represents an exciting part of our pipeline, potentially enabling
millions of people in the United States to forgo their reading
glasses for approximately 3-4 hours of improved vision.”
The Company expects the reprioritization of its
programs to yield overall cost savings to Eyenovia of approximately
$1.5 to $1.9 million in 2020.
Program |
Indication |
2020 Milestones |
Estimated U.S. Market Opportunity |
MicroLine |
Presbyopia |
Initiate and Complete Phase III VISION Study |
$2B+ |
MicroPine |
Progressive Myopia |
Complete Phase III CHAPERONE Enrollment |
$5B+ |
MicroStat |
Mydriasis |
File NDA |
$300M+ |
Conference Call and Webcast
The conference call is scheduled to begin at
5:00 pm ET on Tuesday, October 29, 2019. Participants should dial
1-866-916-2921 (United States) or 1-210-874-7771 (International)
with the conference code 3192808. A live webcast of the conference
call will also be available on the investor relations page of the
Company's corporate website at www.eyenovia.com.
After the live webcast, the event will be
archived on Eyenovia’s website for one year. In addition, a
telephonic replay of the call will be available until November 5,
2019. The replay can be accessed by dialing 1-855-859-2056 (United
States) or 1-404-537-3406 (International) with confirmation code
3192808.
About EyenoviaEyenovia, Inc.
(NASDAQ: EYEN) is a clinical stage ophthalmic biopharmaceutical
company developing a pipeline of microdose therapeutics utilizing
its patented piezo-print delivery technology. 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 MicroLine for
PresbyopiaMicroLine is Eyenovia’s 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.
Eyenovia believes that its high precision microdosing technology
combined with the well-known drug pilocarpine could provide
short-term improvement in vision in patients, lasting approximately
3-4 hours while addressing tolerability and instillation issues
associated with macrodose pilocarpine.
Upcoming Milestone: Initiate and Complete
MicroLine Phase III Trial in 2020
About MicroPine for Progressive
MyopiaMicroPine is Eyenovia's first-in-class topical
treatment for progressive myopia, a back-of-the-eye condition
commonly known as nearsightedness. Progressive myopia is estimated
to affect close to 5 million people 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. Early dose finding studies by
collaborative academic groups have demonstrated high therapeutic
potential with low dose atropine which can reduce myopia
progression by 60 – 70% with a sustained effect through three
years. 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) Upcoming
Milestone: Complete Enrollment of the Phase III CHAPERONE Study in
2020
About MicroStat for
MydriasisMicroStat is Eyenovia's first-in-class
fixed-combination micro-formulation product (phenylephrine 2.5%
-tropicamide 1%) candidate for pharmacologic mydriasis (eye
dilation), which is targeted to address the growing needs of the
estimated 80 million office-based comprehensive and diabetic eye
exams performed every year in the United States, as well as the
estimated 4 million pharmacologic mydriasis applications for
cataract surgery. We are developing MicroStat to improve the
efficacy and tolerability of pharmacologic mydriasis.
Upcoming Milestone: File NDA in 2020
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
with minimal training in 85% of topical medication administrations
compared to 40 – 50% with conventional eyedroppers. Additionally,
its smart electronics and mobile e-health technology are designed
to track and enhance patient compliance.
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: the potential success of our
reprioritized pipeline; any cost savings related to our
reprioritized pipeline; our ability to identify new product
candidates; 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; the
potential advantages of our product candidates; risks involved in
clinical trials, including, but not limited to, the design,
initiation, timing, progress and results of such trials; the timing
and our ability to submit applications for, and obtain and maintain
regulatory approvals for, our product candidates; our ability to
timely develop and implement manufacturing, commercialization and
marketing capabilities and strategies for existing product
candidates; fluctuations in our financial results; our ability to
raise money; 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.
Company Contact:Eyenovia,
Inc.John GandolfoChief Financial
Officerjgandolfo@eyenoviabio.com
Investor Contact:Tram Bui /
Alexander LoboThe Ruth GroupPhone:
646-536-7035/7037tbui@theruthgroup.com / alobo@theruthgroup.com
Media Contact:The Ruth
GroupKirsten ThomasPhone: 508-280-6592kthomas@theruthgroup.com
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