Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic
biopharmaceutical company developing a pipeline of microdose
therapeutics utilizing its patented piezo-print delivery
technology, today confirmed a broad patient population for its
Phase III MicroProst program (microdose latanoprost with Optejet™
delivery) for the lowering of intraocular pressure (IOP). Following
discussions with the U.S. Food and Drug Administration (FDA), the
study population will include chronic angle closure glaucoma
(CACG), as well as open angle glaucoma (OAG) and ocular
hypertension (OHT) patients, representing a total addressable
population of approximately 4 million in the United States. As
anticipated, the Phase III program will be optimized to consist of
a single MicroProst Phase III trial and supplemented with existing
data on latanoprost for IOP lowering.
"We believe that our MicroProst study will
include one of the broadest patient populations in glaucoma drug
development to date. If approved, MicroProst could have one of the
widest indications of commercially available IOP-lowering
therapies, as well as represent the first FDA-approved drug
specifically indicated for chronic angle closure glaucoma,"
commented Dr. Sean Ianchulev, Eyenovia’s Chief Executive Officer
and Chief Medical Officer. "Based on the results of our earlier
Phase II trial for IOP lowering, we believe that MicroProst may
achieve similar clinical efficacy with improved tolerability versus
latanoprost administered in drop form, which can overdose the eye
with potentially harmful preservatives and active ingredient."
“Together, open angle glaucoma and ocular
hypertension represent a larger patient population in the United
States compared to chronic angle closure glaucoma. Having an
FDA-approved drug with all three conditions specified in the label
means that patients who are currently prescribed or are candidates
for prostaglandin therapy may have the option for next-generation,
smart, micro-dose delivery,” said Shan Lin, M.D., Glaucoma
Specialist at the Glaucoma Center of San
Francisco. “MicroProst may open up possibilities for patients
who cannot use current eyedropper treatments due to intolerance to
high-volume drug and preservative, inability to correctly instill
eye drops, or poor compliance.”
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 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 (OHT) and Primary Open Angle Glaucoma (POAG).
|
Updated Plan |
Study Population |
CACG, OHT and POAG |
Phase III Program Enrollment |
Single Phase III trial |
Sample Size |
N250 |
Primary Phase III Endpoint |
IOP lowering from baseline through 3 months |
Total Addressable U.S. Population |
Approximately 4 million |
Feasibility Dose-Finding Studies: MicroProst
Phase II PG21Upcoming Milestone: MicroProst Phase III Trial First
Patient In H1 2019
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 H1 2019;
NDA Filing Q1 2020
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.
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.
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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