Full Press Release Details
Eyenovia Announces Positive Topline Results
from VISION-1 Phase 3 Clinical Study of MicroLine for the Treatment of Presbyopia
Primary endpoint was achieved with well-tolerated
micro-array print (MAP ) safety profile
Upcoming key 12 month milestones include Mydcombi
PDUFA; VISION-2 Phase 3 trial results and completion of enrollment for CHAPERONE Phase 3 trial
NEW YORK-May 25, 2021-Eyenovia,
Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of MAP therapeutics, today
announced positive topline data from its Phase 3 VISION-1 study evaluating the company's proprietary pilocarpine formulation, MicroLine,
for the temporary improvement of near vision in adults with presbyopia. The study achieved its primary endpoint and preparations are underway
for a second Phase 3 registration study, VISION-2. These studies will serve as the basis for a planned New Drug Application (NDA) submission
to FDA. VISION-1 results will be presented at a future ophthalmic-focused medical meeting.
The VISION-1 study evaluated the safety and efficacy
of Eyenovia's 1% and 2% pilocarpine Micro-Array Print formulations versus placebo, all administered via the company's proprietary
Optejet dispenser. VISION-1 is the third Phase 3 study demonstrating the utility of the company's MAP technology in improving
the therapeutic index of topical ophthalmic drugs.
Key highlights from the
pleased at the success of our VISION-1 study, marking another major milestone for our Micro-Array Print platform technology," stated
Dr. Sean Ianchulev, Chief Executive Officer and Chief Medical Officer of Eyenovia. "Along with plans for VISION-2 in the coming
months, we continue to prepare for the potential FDA approval of MydCombi for mydriasis in the fourth quarter and full enrollment
of the CHAPERONE study for pediatric myopia shortly thereafter."
Presbyopia is the age-related,
progressive hardening of the eye's lens, making it difficult for the clear lens of the eye to change shape. Presbyopia causes blurred
near vision and is often corrected with eyeglasses or "readers," contact lenses or surgery. In the 40 to 55 age group, approximately
18 million people in the U.S. are presbyopic, suggesting a multi-billion U.S. market opportunity for MicroLine, if approved.
Dr. Robert Weinreb, Distinguished
Professor and Chair of Ophthalmology at the University of California, San Diego, added, "Besides being a new option for presbyopic
patients, MicroLine also may improve community eye health. Presbyopic patients now often obtain reading glasses without a comprehensive
eye examination. With the potential future availability of MicroLine, such patients instead might seek an eye examination in order
to obtain a prescription for the product."
that presbyopic patients are seeking more options to help them perform common activities, such as reading a menu or glancing at their
smart phone," said April Jasper, OD FAAO and Eyenovia Medical Monitor. "Many of these patients simply purchase reading
glasses without the benefit of a regular eye exam and end up unhappy being dependent on them and because they can make them look older.
The ability to have an option such as MicroLine could address a common request from patients for the freedom to not have to wear glasses
in certain situations."
About the VISION Trials
The VISION trials are Phase 3, double-masked,
placebo-controlled, cross-over superiority trials that will enroll participants with presbyopia. The primary endpoint is binocular distance
corrected near visual acuity. MicroLine is intended for the "on demand" improvement of near vision in people with presbyopia.
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 eye dropper, the Optejet is designed to deliver targeted,
consistent doses more conveniently than typical eyedroppers.
MydCombi is Eyenovia's first-in-class
fixed-combination micro-formulation product (tropicamide 1% - phenylephrine 2.5%) candidate for pharmacologic mydriasis (eye dilation),
which is targeted to improve the efficiency of the estimated 80 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 for use without
anesthetic, Eyenovia is developing MicroStat to help improve the efficacy and tolerability of pharmacologic mydriasis.
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