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 the safety and efficacy results from
the Company’s two Phase 3 trials, MIST-1 and MIST-2, for
pharmacologic mydriasis (pupil dilation). The results were
presented by David Wirta, M.D., from the podium during the joint
American Society of Cataract and Refractive Surgery (ASCRS) and
American Society of Ophthalmic Administrators (ASOA) Annual
Meeting, on May 5, 2019 in San Diego, CA.
The MIST-1 study enrolled 64 subjects, in whom
both eyes were treated on separate days with MicroStat, Eyenovia's
proprietary fixed combination, microdosed ophthalmic solution and
with each component formulation (i.e. tropicamide and
phenylephrine). The MIST-2 study enrolled 70 subjects, in whom both
eyes were treated on separate days with MicroStat and a placebo
solution. All treatments in the MIST-1 and MIST-2 trials were
administered using Eyenovia’s Optejet™ dispenser that allows for
dosing of approximately 8 microliters, which is less than 25% of
the dose volume typically administered with eye dropper
bottles.
In each trial, MicroStat was shown to be safe
and effective for pharmacologic mydriasis achieving clinically and
statistically superior mean pupil dilation. Collective results show
approximately 94% of treated eyes achieved pupil dilation of at
least 6mm at 35 minutes post-instillation. Dilation was rapid in
most patients, with up to 64% of fixed-combination treated eyes
achieving 6mm or greater dilation as early as 20 minutes
post-installation. Adverse events were infrequent (~3% of
subjects), transient, and generally mild in nature.
Dr. Wirta, principal investigator of the
MIST-1 study, said, “We believe these outcomes further validate
ocular microdosing and demonstrate that less can be more – less
preservative and medication exposure still delivers a compelling
ocular biologic effect while sparing the ocular surface from the
toxicity associated with preservatives and some topical
medications.”
Dr. Sean Ianchulev, Eyenovia’s Chief
Executive Officer and Chief Medical Officer, added, “The conclusion
of our two Phase 3 registration studies for MicroStat mark
significant progress in Eyenovia’s pipeline. They validate the
experience from our prior micro-dosing Phase II studies and are
informative and enabling for our forthcoming Phase III trials in
myopic progression and glaucoma. We believe the Optejet
high-precision piezo-print delivery platform can improve the
therapeutic index and tolerability of many ophthalmic therapies
–unlocking the potential of ocular microdosing.”
Terry Kim, M.D., member of Eyenovia’s Scientific
Advisory Board and ASCRS Treasurer, commented, “In addition to
quick and reliable efficacy and an excellent safety profile,
MicroStat may offer additional benefits, including the potential to
minimize cross-contamination seen with dropper bottles because its
unique dispenser has a non-protruding nozzle for no-touch spray
application. I am excited for the potential of this innovative
product to enhance my clinic’s efficiency and improve my patients’
experience.”
All educational content of the ASCRS•ASOA Annual
Meeting is planned by its program committee, and ASCRS•ASOA does
not endorse, promote, approve, or recommend the use of any
products, devices, or services.
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)
Upcoming Milestone: MicroPine Phase III Trial Start 2019
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 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: OTC Monograph Registration
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 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. 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 design, initiation, timing,
progress and results of such trials; the timing and our need and
ability to submit applications for, and obtain and maintain
regulatory approvals for, our product candidates; our ability to
develop and implement commercialization, marketing and
manufacturing capabilities and strategies for existing product
candidates and 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.
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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