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 U.S. Food and Drug
Administration (FDA) has accepted the Company’s Investigational New
Drug (IND) application to initiate the CHAPERONE study - the
Company's Phase III registration trial of MicroPine to reduce the
progression of myopia in children.
Currently, there are no FDA-approved therapies
to slow the progression of myopia, a condition that, if
uncontrolled, can in some cases be associated with major pathologic
changes such as retinal atrophy, macular staphylomas, retinal
detachment and visual impairment. It is estimated that
approximately 9% of children in the United States have myopia
resulting in a potential U.S. market for MicroPine of approximately
$5 billion. Outside of the United States, we estimate the market
potential for MicroPine is even larger – with up to approximately
80% of children starting out myopic in Asian markets. There is a
growing body of evidence that supports the therapeutic effect of
low dose atropine, potentially slowing myopia progression by
60-70%2-3.
“We are very pleased to have received FDA
acceptance of our IND application for the Phase III registration
trial for our MicroPine program. This acceptance allows us to
initiate Phase III trial enrollment in the first half of 2019. Our
work in this area follows in the footsteps of the ATOM 1, ATOM 2,
and LAMP clinical studies performed by academic-collaborative
groups. The American Academy of Ophthalmology recently cited Level
1 evidence4 that topical lower doses of atropine treatment have
demonstrated robust and sustained effect in slowing progressive
myopia by up to 60-70%,” commented Dr. Sean Ianchulev, Eyenovia’s
Chief Executive Officer and Chief Medical Officer. “We believe that
by combining the knowledge gained from these studies with our
OpteJet™, high-precision piezo-print microdose technology, we have
the opportunity to potentially change the odds of progressive
myopia.”
The CHAPERONE study is a U.S.-based,
multi-center, randomized, double-masked trial that will enroll more
than 400 children between 5-12 years of age. Participants will be
equally randomized to receive treatment with either of two
MicroPine treatment concentrations or a placebo control arm.
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 mydriasis, myopia progression, glaucoma, and other
eye diseases. For more Information please visit
www.eyenoviabio.com.
About MicroPine for Progressive
MyopiaMicroPine is Eyenovia's first-in-class topical
treatment for progressive myopia, a back-of-the-eye disease.
Progressive myopia is estimated to affect close to 5 million
patients 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 (Independent Collaborative Group Trials)Upcoming
Milestone: MicroPine Phase III Trial First Patient In H1 2019
About MicroStat for
MydriasisMicroStat is Eyenovia's first-in-class
fixed-combination micro-formulation product
(phenylephrine-tropicamide) 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 help improve
efficacy, usability and tolerability of pharmacologic
mydriasis.
Feasibility Dose-finding Studies: MicroStat Ph
I/II; MicroStat Ph IIRegistration Studies: MicroStat MIST-1 Phase
IIIUpcoming Milestone: MicroStat MIST-2 Phase III Results / NDA
Filing in Q1 2020
About MicroProst for
GlaucomaMicroProst is Eyenovia's proprietary latanoprost
formulation product candidate, which is being developed as a
first-line treatment for the reduction of IOP in patients with
Chronic Angle Closure Glaucoma (CACG), as well as Ocular
Hypertension and Primary Open Angle Glaucoma (POAG). Currently,
there are no FDA-approved therapies specifically indicated for
CACG, which accounts for an estimated 10% and 50% of all glaucoma
diagnoses in the United States and China, respectively. We believe
there are close to 700,000 patients with CACG in the United States
and more than 3.5 million with POAG for whom chronic, often
life-long medication therapy is required.
Feasibility Dose-Finding Studies: MicroProst
Phase II PG21Upcoming Milestone: MicroProst Phase III Trial First
Patient In H1 2019
About MicroTears OTC for Dry
EyeMicroTears is a micro-droplet ocular surface tear
replenishment product candidate for the estimated $2 billion+ (200
million units) global annual OTC artificial tear market.
Upcoming Milestone: OTC Registration H1 2019
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 gentle
ocular surface delivery in less than 80 milliseconds, beating the
ocular blink reflex. The OpteJet's targeted delivery system has
demonstrated 85% topical delivery efficacy compared to 40-50% with
the conventional eyedropper, and its smart electronics and mobile
e-health technology are designed to track and enhance patient
compliance.
References1. Pan CW, Ramamurthy
D, Saw SM. Worldwide prevalence and risk factors for myopia.
Ophthalmic Physiol Opt. 2012;32:3e16.
2. Chua WH, Balakrishnan V, Chan YH, Tong L,
Ling Y, Quah BL, Tan D. Atropine for the treatment of childhood
myopia. Ophthalmology. 2006;113(12):2285–2291.
3. Chia A, Chua WH, Cheung YB, Wong WL, Lingham
A, Fong A, Tan D. Atropine for the treatment of childhood myopia:
safety and efficacy of 0.5%, 0.1%, and 0.01% doses (atropine for
the treatment of myopia 2). Ophthalmology. 2012;119:347–354.
4. Stacy L. Pineles, MD,1 Raymond T. Kraker,
MSPH,2 Deborah K. VanderVeen, MD,3 Amy K. Hutchinson, MD,4 Jennifer
A. Galvin, MD,5 Lorri B. Wilson, MD,6 Scott R. Lambert, MD.
Atropine for the Prevention of Myopia Progression in Children. A
Report by the American Academy of Ophthalmology. Ophthalmology
2017;124:1857-1866.
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. 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: risks involved in clinical trials,
including, but not limited to, the 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, and to raise money, including in light of
U.S. government shut-downs; our ability to develop and implement
commercialization, marketing and manufacturing capabilities and
strategies; the potential advantages of our 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; intellectual property
risks; the impact of government laws and regulations; 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.
Caution: New
Drug―Limited by Federal
(United States) law to investigational use.
Company Contact:Eyenovia,
Inc.John GandolfoChief Financial
Officerjgandolfo@eyenoviabio.com
Investor Contact:Tram Bui /
Alexander LoboThe Ruth Group646-536-7035/7037tbui@theruthgroup.com
/ alobo@theruthgroup.com
Media Contact:The Ruth
GroupKirsten Thomas508-280-6592kthomas@theruthgroup.com
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