MIST-1 study met primary endpoint
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 positive results from the MicroStat
Phase 3 MIST-1 study. The study examined the safety and efficacy of
the Company’s first-in-class, MicroStat fixed-combination
formulation, with target markets including the estimated 80 million
annual pharmacologic mydriasis market in the United States.
The study was a U.S.-based, randomized,
double-masked, superiority trial that enrolled 64 subjects, in whom
both eyes were treated on separate days with Eyenovia's proprietary
MicroStat fixed combination formulation of phenylephrine 2.5% -
tropicamide 1%. MicroStat was compared against each component
formulation of tropicamide and phenylephrine, respectively. All
treatments were administered using Eyenovia’s OpteJet
technology.
For the primary efficacy outcome of mean pupil
dilation at 35 minutes post-administration, the MicroStat group
demonstrated a statistically and clinically superior mydriatic
effect as compared to either component formulation. Additional
outcomes demonstrated 94% of eyes achieved 6 mm or greater pupil
dilation at 35 minutes post-administration. This compared with
78% and 1.6% for the tropicamide-only and phenylephrine-only
groups, respectively. At 20 minutes, 57% of the MicroStat-treated
eyes achieved 6 mm dilation or greater versus 38% of the
tropicamide treated eyes and none in the phenylephrine treated
eyes.
Dr. Sean Ianchulev, Eyenovia’s Chief Executive
Officer and Chief Medical Officer commented, “We are excited with
the results of the Phase 3 MIST-1 study. The MicroStat
fixed-combination administered with the OpteJet delivered strong
efficacy and was well tolerated by all subjects. We believe this is
the first time in a Phase III FDA registration program that drugs
have been delivered to the ocular surface using a smart microdose
eyedropper-free delivery system – a meaningful step forward as we
try to modernize the legacy eyedropper paradigm. These data from a
well-controlled FDA registration study further validate our
microdose technology platform and support our extensive clinical
development pipeline for other microdosed ophthalmic solutions. We
look forward to announcing topline data from our MIST-2 study in
short order.”
Dr. David Wirta, MD, principal investigator of
the MIST-1 study added, “There are an estimated 80 million
in-office exams performed each year in the United States requiring
mydriasis, an integral part of comprehensive eye exams. Eyenovia’s
MIST-1 study results demonstrate that not only does MicroStat
successfully induce significant pupil dilation, but it does so
rapidly. We believe that having a fixed combination option to
achieve mydriasis has the potential to streamline the in-office
examination process, potentially increasing physician efficiency
and patient through-put volume.”
The Company expects to present the detailed
results from the MIST-1 trial in a forthcoming scientific
forum.
Conference Call Information
Eyenovia will host a conference call and webcast
with slides today, January 30, 2019 at 8:30 AM Eastern to discuss
the topline results of the MIST-1 study. Participants should dial
1-866-916-2921 (United States) or 1-210-874-7771 (International)
with the conference code 2699153. A live webcast of the conference
call will also be available on the investor relations page of the
Company's corporate website at www.eyenoviabio.com.
After the live webcast, the event will be
archived on Eyenovia’s website for one year. In addition, a
telephonic replay of the call will be available until February 6,
2019. The replay can be accessed by dialing 1-855-859-2056 (United
States) or 1-404-537-3406 (International) with confirmation code
2699153.
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 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 IIUpcoming Milestone: NDA Filing In Q1 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 (Independent Collaborative Group Trials)Upcoming
Milestone: MicroPine Phase III Trial First Patient In H1 2019
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 fast and
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.
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 GroupPhone:
646-536-7035/7037tbui@theruthgroup.com / alobo@theruthgroup.com
Media Contact:The Ruth
GroupKirsten Thomas508-280-6592kthomas@theruthgroup.com
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