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 Professor Mark Bullimore, PhD and
April Jasper, OD have joined Eyenovia’s Scientific Advisory Board.
“We are very pleased to welcome two highly
accomplished and respected optometrists to our Scientific Advisory
Board,” commented Dr. Sean Ianchulev, Eyenovia’s Chief Executive
Officer and Chief Medical Officer. “We believe Professor Mark
Bullimore and Dr. April Jasper will bring a wealth of scientific,
academic and practical experience in optometry and more
specifically in childhood myopia and presbyopia to our company. We
look forward to leveraging their experience as we continue
enrolling patients in our Phase III CHAPERONE study for progressive
myopia and prepare to initiate our Phase III VISION studies for
presbyopia in 2020.”
Professor Mark Bullimore is an internationally
renowned scientist, speaker, and educator. He is currently an
Adjunct Professor at the University of Houston College of Optometry
and is also the Associate Editor of Ophthalmic and Physiological
Optics. He is a Fellow of the American Academy of Optometry and a
Gold Fellow of the Association for Research in Vision and
Ophthalmology. Previously, he was the Dean of the Southern
California College of Optometry at Marshall B. Ketchum University
and Editor of Optometry and Vision Science. He received his
Optometry degree and PhD in Vision Science from Aston University in
Birmingham, England.
Dr. April Jasper has extensive experience in
various modes of optometric practice and currently owns and
operates Advanced Eyecare Specialists, a group optometry practice
in West Palm Beach, Florida. Dr. Jasper is a Benedict Professor in
practice management at Houston College of Optometry and a community
leader. Dr. Jasper is also Chief Optometric Editor of Optometric
Management magazine, a fellow of the American Academy of Optometry
and Past-President of the Florida Optometric Association. Dr.
Jasper received her degree in Optometry from Nova Southeastern
University and completed her residency in primary care, ocular
disease and contact lenses in Boston, Massachusetts where she also
held a position as adjunct professor at the New England College of
Optometry.
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.
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.
Upcoming Milestone: Initiate and Complete Phase
III VISION Trials in 2020
About MicroPine for Progressive
MyopiaMicroPine (atropine ophthalmic solution) 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
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)
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 improve the efficiency 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. Developed for use without anesthetic, 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
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.
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 attract and retain
key members of our company; fluctuations in our financial results;
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; 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:The Ruth
GroupTram Bui / Alexander LoboPhone:
646-536-7035/7037tbui@theruthgroup.com / alobo@theruthgroup.com
Media Contact:The Ruth
GroupKirsten ThomasPhone: 508-280-6592kthomas@theruthgroup.com
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