Full Press Release Details
Eyenovia's EYN PG21 Trial Evaluating
High-Precision Microdose of Latanoprost Demonstrates Robust Intraocular Pressure Lowering and Patient Usability
Positive results validate Eyenovia's
piezo-print technology for topical eye treatment as Company prepares for Phase III trials in progressive myopia, CACG and mydriasis
New York, NY - August 13, 2018
- Eyenovia, Inc. (NASDAQ: EYEN), a biopharmaceutical company developing a pipeline of ophthalmology products utilizing
its patented piezo-print technology to deliver microdosed medications topically to the eye, today announced positive results of
its EYN PG21 proof-of-concept study of microdose latanoprost for the lowering of intraocular pressure (IOP) and patient usability.
The EYN PG21 clinical study investigated
the medication administration effectiveness and IOP lowering effect of microdose latanoprost 0.005% in 60 eyes of 30 healthy volunteers.
Participants received once daily microdose treatment over 2 consecutive days and underwent diurnal (4 times/day) IOP assessments.
The primary outcome was success of microdose delivery, with additional outcomes evaluating diurnal IOP change each day.
In the study, after a brief medication
administration training session, investigators successfully administered high-precision piezo-print latanoprost with a single spray
95% of the time. A separate evaluation of patient self-administration showed an 88% success rate following limited training. This
is a substantive improvement from the 39%-47% success rate reported in the literature using a conventional eyedropper. In addition,
each single medication administration was within 1 L of the prescribed dose and the tear capacity of the eye. This differs
from traditional eyedropper administration, which may deliver as much as 300% more drug than the eye can hold with high variability
The study results also demonstrated that,
while reducing drug administration volume by 75% by delivering the microdose accurately and directly on the corneal surface, piezo-print
micro-formulated latanoprost achieved a very robust reduction in diurnal IOP of up to 29% from baseline unmedicated IOP. This is
consistent with the reported reduction of up to 26% achieved with the same concentration of standard latanoprost eye drops.
Ianchulev, Eyenovia's Chief Executive Officer and Chief Medical Officer, commented,
"We believe these compelling results further validate Eyenovia's high-precision microdosing smart technology and build
on the positive results from our Phase II mydriasis study. These data are very informative for all of our upcoming Phase III programs
in prevention of myopia progression, chronic angle closure glaucoma and mydriasis by demonstrating that medications applied with
our piezo-print technology are both effective and easy for patients to use."
Dr. Louis R. Pasquale, MD, FARVO, Professor
of Ophthalmology at Harvard Medical School, commented, "Conventional eye drops may overdose the eye's tear film capacity
by as much as 300%, causing significant ocular and systemic side effects leading to hyperemia, sunken globe (peri-orbitopathy),
pharmacologic dermatitis and bradycardia, and ultimately the poor compliance that plagues almost all front-of-the-eye treatments.
Microdosing has the potential to address all those problems by providing physiologic high-precision dosing to the eye that stays
Dr. Robert N. Weinreb, Chairman and Professor
of Ophthalmology at the University of California, San Diego, added, "Following Eyenovia's earlier studies, these data
demonstrate that microdosing can open a new chapter in topical eye disease therapy with high-precision microdosing that dramatically
improves the therapeutic index of many front-of-the-eye therapies. Eyenovia's upcoming Phase III programs in myopia, glaucoma
and mydriasis are first-in-class indications that have the potential to introduce a new wave of formulations with improved safety,
tolerability and smart-compliance monitoring."
Eyenovia, 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 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; our ability to attract
and retain key personnel; 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; our ability to identify additional
products, product candidates or technologies with significant commercial potential that are consistent with our commercial objectives;
our expectations regarding our ability to fund our operating expenses and capital expenditure requirements; the impact of government
laws and regulations; our competitive position; and general economic conditions. 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.
Chief Financial Officer
Tram Bui / Alexander Lobo
Phone: 646-536-7035/7037
E-mail: tbui@theruthgroup.com / alobo@theruthgroup.com