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Eyenovia Announces First Patients Enrolled in Phase 3 Study of MicroLine for Presbyopia Topline Results Expected First Half of 2021

Key Takeaway: Eyenovia Announces First Patients Enrolled in Phase 3 Study of MicroLine for Presbyopia Topline Results Expected First Half of NEW YORK-December 16, 2020-Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose a

Full Press Release Details

Eyenovia Announces First Patients Enrolled
in Phase 3 Study of MicroLine for Presbyopia
Topline Results Expected First Half of
NEW YORK-December 16, 2020-Eyenovia,
Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline
of microdose array print (MAP ) therapeutics, today announced that the first set of patients has been enrolled in the Company's
Phase 3 VISION-1 study of MicroLine, its proprietary pilocarpine formulation delivered via its Optejet dispenser, for the
improvement in near vision in patients with presbyopia.
Presbyopia, the age-related hardening of the lens causing blurred
near vision, affects approximately 113 million Americans. Vision impairment typically begins after age 40 and is often corrected
with eyeglasses or "readers," contact lenses or surgery.
"Eyenovia's VISION studies are designed to demonstrate
improvement in near visual acuity in patients with presbyopia. Along with mydriasis and myopia, this is our third Phase 3 program
using our smart Optejet system, which is the first technology of which we are aware to demonstrate the benefits in Phase 3 trials
of topical ophthalmic therapies using high precision, targeted microdosing," said Dr. Sean Ianchulev, Chief Executive Officer
and Chief Medical Officer of Eyenovia. "With our first set of patients now enrolled in the Phase 3 VISION-1 study, we expect
to complete enrollment relatively quickly and have topline data in the first half of 2021, subject to any impacts of COVID-19."
The VISION trials are Phase 3, double-masked,
placebo-controlled, cross-over superiority trials that will each enroll approximately 100 participants between the ages of 40 and
60 who suffer with visual impairment from presbyopia. The primary endpoint is same-day improvement of binocular distance corrected
near visual acuity. MicroLine is designed for use "on demand" for symptomatic improvement of near vision impairment
secondary to presbyopia.
"For the large percentage of
my patients who have no prior vision impairment, developing presbyopia can be a life-altering event as they come to terms with
one of the first outward signs of aging," said Dr. David Wirta of the Eye Research Foundation in Newport Beach, California,
a VISION-1 study investigator. "MicroLine has the potential to remove my patients' dependance on reading glasses by
providing an easy-to-use pharmaceutical treatment that could add to our options in treating this condition."
Dr. William Flynn, Director of Eye
Associates Research Center of San Antonio, Texas and a VISION-1 study investigator added, "Many patients find transitioning
from no glasses to reading glasses has a significant impact on their quality of life. By providing a way to minimize this impact
so that glasses are not needed in all situations, we have the potential to help improve our patients' treatment satisfaction."
Eyenovia's MicroLine is a proprietary
microdosed formulation of pilocarpine for presbyopia that is delivered via the Company's Optejet dispenser. Providing high
precision microdosing at approximately 1/5th the drug volume of a traditional eyedropper, the Optejet is designed to
deliver targeted, consistent doses more conveniently than typical eyedroppers.
About Eyenovia, Inc.
Eyenovia, Inc. (NASDAQ: EYEN) is a clinical stage ophthalmic
biopharmaceutical company developing a pipeline of microdose array print (MAP) therapeutics. Eyenovia is currently focused on
the late-stage development of microdosed medications for presbyopia, myopia progression and mydriasis. For more Information, visit www.eyenovia.com.
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, including estimated market opportunities
for our product candidates and platform technology. 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 U.S. Securities and Exchange Commission. In addition, such statements
could be affected by risks and uncertainties related to, among other things: risks of our clinical trials, including, but not limited
to, the costs, design, initiation and enrollment (which could still be adversely impacted by COVID-19 and resulting social distancing),
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; the potential impacts of COVID-19 on our supply chain; the potential advantages of our product
candidates and platform technology; 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; reliance on third parties to develop and commercialize
our product candidates; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization
and marketing capabilities and strategies for our product candidates; intellectual property risks; changes in legal, regulatory
and legislative environments in the markets in which we operate and the impact of these changes on our ability to obtain regulatory
approval for our products; 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, Eyenovia does not undertake any obligation to update
any forward-looking statements.
Chief Financial Officer
Eyenovia Investor Contact:
LifeSci Advisors, LLC
Eyenovia Media Contact:
Pazanga Health Communications
Last updated: Dec 16, 2020