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 it has initiated its MicroPine
Phase III program with the first patient enrolled in its CHAPERONE
study.
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 will
investigate 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 change in refractive error from baseline through 36
months.
Currently, there are no FDA-approved
therapeutics for the treatment of pediatric progressive myopia - a
back-of-the-eye disease characterized by uncontrolled
sclero-retinal axial elongation leading to myopia and potential
associated pathologic changes, such as retinal atrophy, macular
staphylomas, retinal detachment and visual impairment. It is
estimated that close to 22% of young adults and children in the
United States suffer from myopia, with progressive prevalence in
the Caucasian population increasing more than 10-fold between the
ages of 5 and 18 years, while in some regions in Asia, up to 80% of
children are reported to be myopic1,2.
“We are very pleased to have initiated
enrollment in our Phase III CHAPERONE study. This program
could set some first-in-class precedents – not only as the first
therapeutic indicated for myopic progression, but also the first
topical therapy for a back-of-the-eye disease. Level 1 evidence
from recent academic, collaborative, randomized trials such as
ATOM1, ATOM2 and LAMP have established that low concentration
atropine eye drops can slow progressive myopia by up to
60-70%3-4 with an acceptable risk-benefit profile, and could
be a game-changer in our efforts to fight the global myopia
epidemic. We plan to use the CHAPERONE study, along with the
existing evidence from the previous academic collaborative
trials, to submit for the FDA approval of MicroPine,”
commented Dr. Sean Ianchulev, Eyenovia’s Chief Executive
Officer and Chief Medical Officer.
Dr. Pamela Gallin, Clinical Professor of
Ophthalmology in Pediatrics and Director Emeritus, NY Presbyterian
– Columbia University Medical Center added, “CHAPERONE will
evaluate the benefit of slowing the progression of myopia with a
microdose of low concentration atropine. This may reduce the
problems associated with high myopia, including a range of retinal
complications.”
“I believe some of the current challenges faced
by clinicians and families exploring myopia control with
atropine are adherence and side effects with long term treatment,”
commented Dr. Danielle Iacono, Assistant Clinical Professor at SUNY
College of Optometry and one of the Principal Investigators within
the CHAPERONE study. “The Eyenovia micro-dosed atropine
formulation to be evaluated in the CHAPERONE study delivers less
drug in such a way that it could increase adherence to treatment
and reduce adverse effects. Since these factors are paramount
to the success of all ocular medication, I am excited to
begin enrolling patients into this study, which at its conclusion
will inform myself and other eye care providers as to the safety
and efficacy of this novel approach to myopia control.”
Frequently Asked Questions about
Pediatric Progressive Myopia (PPM)
What is pediatric progressive myopia (PPM)?
PPM is nearsightedness in children that worsens
year after year. This progression may result in severe (or
high) myopia, which can be associated with potentially serious side
effects including loss of vision5.
How common is PPM?
In 2016, there were an estimated 30 million
children with myopia in the United States alone, of which
approximately 5 million would be considered highly myopic.
Worldwide, it is estimated that the number of individuals who are
myopic could reach up to 4.7 billion, with 900 million of those
forecast to be highly myopic by 20506,7.
How does PPM differ from the myopia that
millions of adults live with?
Myopia that presents later in life tends not to
progress, making it more easily corrected by glasses or contact
lenses and often not associated with the potential long-term
consequences of pediatric progressive myopia.
What are some of the potential long-term
consequences of PPM?
Severe myopia after years of PPM in childhood is
a leading cause of functional vision loss, which can in certain
cases lead to retinal detachment, glaucoma, cataracts, choroidal
neovascularization, staphyloma and myopic macular
degeneration8.
What is atropine?
Atropine is a well-established drug that has a
wide range of uses including as a systemic agent to block the
effects of nerve agents to treating strabismus or “lazy eye” when
used as a higher concentration eyedrop.
What evidence is there that low concentration
atropine can reduce the progression of PPM?
Administration of low concentration atropine
eyedrops has been demonstrated to be a promising modality to slow
PPM in multiple large clinical studies conducted primarily in Asia,
including ATOM13, ATOM24 and LAMP9.
Is atropine used today in patients with PPM?
There is currently no FDA-approved atropine product for
treatment of PPM. Low concentration atropine eyedrops that are
specially compounded by pharmacies are used by some patients to
reduce the progression of the disease; however, these formulations
are not shelf-stable over a long period of time, with the potential
to affect potency as well as batch-to-batch variability. Also,
because compounded eye medications are not subjected to the rigors
of FDA premarket review, their safety and efficacy have not been
well-characterized and in some cases have led to adverse
events10.
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.eyenovia.com.
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: NDA Filing 2020
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; LAMP (Independent Collaborative Group Trials)
About MicroProst for Glaucoma and Ocular
HypertensionMicroProst 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 Primary Open
Angle Glaucoma (POAG) and Ocular Hypertension. 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
approximately 500,000 patients with CACG in the United States and
approximately 3.0 million with POAG for whom chronic, often
life-long medication therapy is required. Feasibility Dose-Finding
Studies: MicroProst Phase II EYN PG21Upcoming Milestone: MicroProst
Phase III Trial Start End of 2019
About MicroTears OTC for Hyperemia,
Pruritis and Dry EyeMicroTears is a micro-droplet ocular
hyperemia (red eye), pruritis (itch) and ocular lubrication product
candidate for the approximately $850 million annual OTC artificial
tear market in the United States.
Upcoming Milestone: Commercial launch to
coincide with potential MicroStat commercialization
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.
References
- Pan CW, Ramamurthy D, Saw SM. Worldwide prevalence and risk
factors for myopia. Ophthalmic Physiol Opt. 2012;32:3e16.
- Rudnicka, A. R., Kapetanakis, V. V., Wathern, A. K., Logan, N.
S., Gilmartin, B., Whincup, P. H., Owen, C. G. Global variations
and time trends in the prevalence of childhood myopia, a systematic
review and quantitative meta-analysis: Implications for aetiology
and early prevention. British Journal of Ophthalmology, 100(7),
882-890. doi:10.1136/bjophthalmol-2015-307724
- 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.
- 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.
- Heiting, G. (2018, September). What is High Myopia?
Retrieved from
https://www.allaboutvision.com/conditions/myopia-faq/high-myopia.htm
- Theophanous C., Modjtahedi B., Batech M., Marlin D., Luong T.,
Fong D. Myopia prevalence and risk factors in children. Clinical
Ophthalmology. 2018;12:1581–1587. doi: 10.2147/opth.s1646
- Holden BA, Fricke TR, Wilson DA, et al. Global prevalence of
myopia and high myopia and temporal trends from 2000 through 2050.
Ophthalmology. 2016;123(5):1036–1042.
- Holden BA, Wilson DA, Jong M, et al. Myopia: a growing global
problem with sight-threatening complications. Community Eye Health.
2015;28:35.
- Yam JC, Jiang Y, Tang SM, Law AKP, Chan JJ, Wong E, et al.
Low-concentration atropine for myopia progression (LAMP) study: a
randomized, double-blinded, placebo-controlled trial of 0.05,
0.025, and 0.01% atropine eye drops in myopia control.
Ophthalmology. 2018;126(1):113–124. doi:
10.1016/j.ophtha.2018.05.029
- Daily Mail September 21, 2018 Health Column. Mia De Graaf
author.
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: our ability to raise money; 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 identify new product
candidates; 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; 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.
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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