Eyenovia Resumes Recruitment of Phase III CHAPERONE Study for Progressive Myopia
June 30 2020 - 04:05PM
Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic
biopharmaceutical company developing a pipeline of microdose array
print (MAP™) therapeutics, today announced that the Company has
resumed patient enrollment for its Phase III CHAPERONE study for
the treatment of progressive myopia, following a temporary pause
due to the COVID-19 pandemic.
“We are excited to resume enrollment in our
Phase III CHAPERONE study among nearly all of our clinical sites
for the treatment of progressive myopia in children. Despite
conditions caused by COVID-19, we continued to follow-up with and
monitor previously enrolled CHAPERONE patients via telemedicine and
remote monitoring processes. We are pleased to report that
all patients previously randomized to treatment have continued to
progress in the study. We are working in close partnership with our
investigational sites as we advance to complete trial enrollment,
which will depend on the continued improvement of the COVID-19
pandemic,” commented Dr. Sean Ianchulev, Eyenovia’s Chief Executive
Officer and Chief Medical Officer. "
The CHAPERONE study is a U.S.-based,
multi-center, randomized, double-masked trial that will enroll more
than 400 children between 3-12 years of age. The study is
investigating the safety and efficacy of MicroPine for the
reduction of progressive myopia using Eyenovia’s proprietary
atropine topical micro-formulation delivered by the Optejet™
dispenser. Subjects will be randomized to receive treatment with
either of two MicroPine concentrations or a placebo. The primary
endpoint of the study is the proportion of eyes with < 0.5 D
increase in refractive error from baseline through 36 months.
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 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)
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 may provide a meaningful improvement in near
vision while enhancing tolerability and usability.
About MicroStat for
MydriasisMicroStat is Eyenovia's first-in-class
fixed-combination micro-formulation product (tropicamide 1% -
phenylephrine 2.5%) 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.
About Optejet™ and MicroRx Ocular
TherapeuticsEyenovia's Optejet microdose formulation and
delivery platform for ocular therapeutics uses high-precision
piezo-print technology to deliver approximately 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: impacts of and uncertainty related
to COVID-19; 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;
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; the potential success of our
reprioritized pipeline; any cost savings related to our
reprioritized pipeline; 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; our
ability to timely develop and implement anticipated manufacturing,
commercialization and marketing capabilities and strategies for
existing product candidates; 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.
Company Contact:Eyenovia,
Inc.John GandolfoChief Financial Officerjgandolfo@eyenovia.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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