MIST-2 study meets 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 its second
MicroStat Phase III study, called MIST-2. 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 MIST-2 study was a U.S.-based, multi-center, randomized,
double-masked, superiority trial that enrolled 70 subjects, in whom
both eyes were treated on separate days with Eyenovia's proprietary
MicroStat fixed combination formulation of phenylephrine 2.5% and
tropicamide 1%. MicroStat was compared against a placebo solution,
both of which were administered using Eyenovia’s Optejet™
dispenser.
For the primary efficacy outcome of mean pupil dilation at 35
minutes post-administration, MicroStat was clinically and
statistically superior to placebo in terms of mydriatic effect,
with a treatment group difference of 4.6 mm. Additional outcomes
demonstrated that, in the MicroStat group, 93% of eyes achieved 6
mm or greater pupil dilation and 68% of eyes achieved 7 mm or more
pupil dilation at 35 minutes post-administration. None of the
eyes in the placebo group achieved similar results.
Dr. Sean Ianchulev, Eyenovia’s Chief Executive Officer and Chief
Medical Officer commented, “The MIST-2 study outcomes are
consistent with those from our first MicroStat Phase 3 study,
MIST-1, in which the safety and efficacy of MicroStat was compared
to its individual product components of phenylephrine 2.5% and
tropicamide 1%. We are pleased to see that the outcomes of these
two Phase III studies continue to validate the bioavailability and
efficacy of microdose drug administration to the ocular surface
using Eyenovia’s Optejet dispenser.”
Dr. William Flynn, MD, principal investigator of the MIST-2
study added, “These results confirm that a novel fixed combination
of the two mydriatic agents currently used individually can provide
a real benefit to eye care practitioners. I look
forward to when this combination becomes available, as it has the
potential to positively impact the efficiency of my practice and
the satisfaction of my patients.”
The Company expects to present the detailed results from the
MIST-2 trial at the American Academy of Cataract and Retinal
Surgery (ASCRS) meeting in May 2019.
About Eyenovia Eyenovia, 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 Mydriasis MicroStat 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.
About MicroPine for Progressive Myopia
MicroPine 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 Glaucoma MicroProst 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
PG21 Upcoming Milestone: MicroProst Phase III Trial First
Patient In H1 2019
About MicroTears OTC for Dry Eye MicroTears 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 Therapeutics
Eyenovia'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 Statements Except 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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