Full Press Release Details
Announces First Patient Enrolled in Phase 3 VISION-2 Trial of MicroLine for Presbyopia
Vision-2 follows successful Vision-1 trial with
expected top-line results in Q2 2022
Presbyopia represents a multi-billion-dollar
market opportunity in the U.S. alone
NEW YORK, Nov. 04, 2021 (GLOBE NEWSWIRE) -- Eyenovia,
Inc. (NASDAQ: EYEN), an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print (MAP )
therapeutics, today announced that the first patient has been enrolled in the Company's second Phase 3 clinical trial of MicroLine,
its proprietary pilocarpine formulation for temporary improvement in near vision (presbyopia), known as VISION-2.
"Following the completion of VISION-1 study, we are pleased to
initiate this second Phase 3 trial that, if successful, will contribute to the clinical evidence supporting a new drug/device combination
application to the US FDA," stated Sean Ianchulev, Chief Executive Officer and Chief Medical Officer of Eyenovia. "By leveraging
the numerous benefits of our microdose array print (MAP ) technology, we believe MicroLine has the potential to be among the first
drug treatments to improve blurred near vision that can adversely impact quality of life in patients with presbyopia."
"Additionally, with 18 million people between the ages of 40
and 55 in the US afflicted with presbyopia, this is a significant market opportunity for our company - in excess of several billion
dollars according to very recent third-party market research. We look forward to continuing to advance this promising and differentiated
therapeutic through late-stage development for the potential benefit of patients, eye care practitioners and shareholders alike."
The VISION-2 study is a double-masked, placebo-controlled, cross-over
superiority trial in which approximately 140 subjects with presbyopia will be treated. During the study, subjects will be randomly assigned
to a treatment sequence for dosing with pilocarpine 2% as well as placebo, both administered via the Optejet dispenser. The primary
endpoint is improvement in high contrast binocular distance corrected near visual acuity measured in low light conditions 2 hours after
treatment. Topline data is expected in mid-2022.
In May 2021, Eyenovia announced positive results from the first Phase
3 MicroLine study, VISION-1. In that trial, the primary endpoint was achieved with MicroLine 2% statistically superior to placebo, determined
by improvement in high contrast binocular distance corrected near visual acuity measured in low light conditions 2 hours after treatment.
Further, MicroLine was very well tolerated; adverse events reported were all mild and transient in nature including fewer than 3% of patients
reporting brow/headache. In a post-study survey, 70% of study participants reported strong interest in using MicroLine for near vision
improvement should it be approved. These patients said they would expect to use the product three to four times per week on average.
About the VISION Trials
The VISION trials are Phase 3, double-masked, placebo-controlled,
cross-over superiority trials that enroll participants with presbyopia. The primary endpoint is improvement in high-contrast binocular
distance corrected near visual acuity in low light conditions. MicroLine is intended for the "on demand" improvement of near
vision in people with presbyopia.
About MicroLine for Presbyopia
MicroLine (pilocarpine ophthalmic solution) is Eyenovia's investigational
pharmacologic treatment for presbyopia. Presbyopia or farsightedness is the non-preventable, age-related hardening of the lens, which
causes a gradual loss of the eye's ability to focus on nearby objects and is estimated to affect nearly 113 million Americans. Treatment
options are typically device-based, such as reading glasses and contact lenses. Pilocarpine ophthalmic solution is known to constrict
the pupil and improve near-distance vision by creating an extended depth of focus through its small aperture effect. Eyenovia believes
that its administration of pilocarpine using the Company's high precision microdosing technology could provide a meaningful improvement
in near vision while enhancing tolerability and usability. MicroLine has been licensed to Arctic Vision (Hong Kong) Limited in Greater
China and South Korea.
About MicroPine for Progressive Myopia
MicroPine (atropine ophthalmic solution) is Eyenovia's investigational,
potentially first-in-class topical treatment for the reduction of pediatric myopia progression, also known as nearsightedness, in children
ages 3-12. It has been developed for comfort and ease-of-use in children, and its microdose administration is designed to potentially
result in low systemic and ocular drug exposure. MicroPine has been licensed to Bausch Health Companies, Inc. in the United States and
Canada, and Arctic Vision (Hong Kong) Limited in Greater China and South Korea.
About MydCombi for Mydriasis
MydCombi is Eyenovia's investigational, first-in-class fixed-dose-combination
product (tropicamide 1% and phenylephrine 2.5% ophthalmic solution) for pharmacologic mydriasis (eye dilation), which is targeted to improve
the efficiency of the estimated 100 million office-based comprehensive eye exams performed every year in the United States, as well
as the estimated 4 million pharmacologic mydriasis applications for cataract surgery. Developed as a micro-formulation for use without
anesthetic, Eyenovia believes MydCombi will help improve the efficacy, tolerability, and efficiency of pharmacologic mydriasis.
MydCombi has been licensed to Arctic Vision (Hong Kong) Limited in Greater China and South Korea.
About Optejet and Microdose Array Print (MAP )
Eyenovia's Optejet microdose formulation and delivery platform
for ocular therapeutics uses high-precision piezo-print technology to deliver 6-8 L of drug, consistent with the capacity of the tear
film of the eye. We estimate the volume of ophthalmic solution administered with the Optejet is less than 20% 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, where solution is dispensed to the ocular surface in approximately
80 milliseconds, beating the ocular blink reflex. Successful use of the Optejet has been demonstrated more than 85% of the time after
basic training in a variety of clinical settings compared to 40 - 50% historically seen with conventional eyedroppers. Additionally,
its smart electronics and mobile e-health technology are designed to track and enhance patient compliance.
About Eyenovia, Inc.
Eyenovia, Inc. (NASDAQ: EYEN) is an ophthalmic pharmaceutical
technology company developing a pipeline of microdose array print (MAP) therapeutics. Eyenovia is currently focused on the late-stage
development of microdosed medications for mydriasis, presbyopia and myopia progression. For more information, visit Eyenovia.com.
The Eyenovia Corporate Information slide deck may be found at ir.eyenovia.com/events-and-presentations.
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 in some
cases 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 of, and our ability to submit applications for, obtaining and maintaining 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