Eyenovia Completes Patient Enrollment in MicroStat MIST-1 Study and Enrolls First Patient in MIST-2 Study
December 03 2018 - 9:00AM
Eyenovia, Inc. (NASDAQ: EYEN) today announced that it has completed
patient enrollment in its Phase III MIST-1 study and enrolled the
first patient in its second Phase III study, the MIST-2 trial, for
the Company’s Phase III MicroStat program for pharmacologic
mydriasis, or dilation of the pupil for an eye exam.
Dr. Sean Ianchulev, Eyenovia’s Chief
Executive Officer and Chief Medical Officer commented, “We are
pleased to have swiftly completed enrollment in the Phase III
MIST-1 study, our first pivotal trial of MicroStat for
pharmacologic mydriasis, in line with our recruitment expectations.
In rapid succession we have also enrolled the first patient in
MIST-2, the second pivotal trial in the MicroStat program.
Pharmacologic mydriasis is an important part of an estimated 80
million office-based comprehensive and diabetic eye exams performed
each year in the United States and remains essential for the
standard dilated retinal fundoscopic examination. We are confident
that our micro-dosed fixed-combination of phenylephrine and
tropicamide holds the potential to initiate a pivotal shift in how
drugs are delivered to the eye and we look forward to announcing
topline results from both trials in the first half of 2019.”
The MIST studies will investigate the safety and
efficacy of the Company’s first-in-class fixed-combination
phenylephrine 2.5% - tropicamide 1% ophthalmic solution,
administered as a micro-dose using the Optejet™ dispenser.
The two Phase III trials are randomized,
double-blind, multicenter-superiority studies, which will each
enroll approximately 65 participants in the United States. In the
MIST-1 study, both eyes of the participants will be treated on
separate days with Eyenovia’s proprietary fixed combination
mydriatic solution and each of the component solutions. In the
MIST-2 study, participants will receive Eyenovia’s fixed
combination mydriatic solution and a placebo on separate days. All
treatments will be administered using the Optejet dispenser. The
primary endpoint for both studies is the mean change in baseline
pupil diameter at 35 minutes after administration of study
treatment.
About EyenoviaEyenovia, Inc.
(NASDAQ: EYEN) is a specialty biopharmaceutical company building a
portfolio of next generation topical eye treatments based on its
proprietary delivery and formulation platform for microdosing.
Eyenovia’s pipeline is currently focused on the late-stage
development of microdosed medications for myopia progression,
glaucoma, mydriasis and other eye diseases.
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, obtain and maintain regulatory approvals for, our
product candidates; 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:The Ruth
GroupTram Bui / Alexander LoboPhone:
646-536-7035/7037tbui@theruthgroup.com / alobo@theruthgroup.com
Media Contact:The Ruth
GroupKirsten Thomas508-280-6592kthomas@theruthgroup.com
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