Full Press Release Details
Eyenovia Announces FDA Approval of Mydcombi ,
the First Ophthalmic Spray for Mydriasis, Which Also Leverages
the Company's Proprietary Optejet Device Platform
Represents the first FDA approved fixed-combination
of tropicamide and phenylephrine for mydriasis
Provides critical validation of key technology
that is core to Eyenovia's proprietary development programs as well as current and future partnerships
NEW YORK- May 8, 2023-Eyenovia, Inc. (NASDAQ: EYEN), an
ophthalmic technology company developing the Optejet device for use both in connection with its own drug-device therapeutic product
candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced that the
U.S. Food and Drug Administration (FDA) has approved Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for inducing mydriasis
for diagnostic procedures and in conditions where short term pupil dilation is desired. This represents the first approved fixed dose
combination of tropicamide and phenylephrine in the United States and also the first product using Eyenovia's proprietary Optejet
device to be approved by any regulatory authority.
Mydcombi is designed to improve the efficiency of the estimated 106
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. The product is contraindicated and should not be used in patients with known hypersensitivity
to any component of the formulation.
"The approval of Mydcombi, our first FDA
approved product, represents the culmination of years of tireless effort by the entire Eyenovia team, and I would like to express my sincere
gratitude to the associates and technical experts who helped advance this important program through this transformational milestone,"
stated Michael Rowe, chief executive officer of Eyenovia. "We look forward to introducing Mydcombi to key offices beginning this
summer while we bring our internal manufacturing capabilities on-line for 2024."
"Perhaps more importantly, FDA approval
of Mydcombi provides critical validation of the Optejet as it is the first product approved using the Optejet platform, which is core
not only to our internal development programs, including MicroLine for presbyopia, but our partnered programs as well. We see opportunities
to unlock significant opportunities in the future treatment of other ophthalmic conditions including glaucoma and dry eye. I am confident
in our ability to maintain our current momentum."
"I am proud of our team for this significant
achievement - which represents many firsts' for eye care," stated Dr. Sean Ianchulev, Founder and Chairman of
Eyenovia's Board of Directors. "The use of eye dropper bottles has presented challenges for dosing in ophthalmologic settings
in millions of patients. We can do better now using sophisticated micro-array print delivery with physiologic dosing that is similar to
the natural tear film volume."
Eyenovia management will provide additional updates
on Mydcombi as well as its ongoing development programs and partnerships during its regularly scheduled first quarter 2023 update conference
call and webcast on May 11th, 2023.
IMPORTANT SAFETY INFORMATION for MYDCOMBI (tropicamide
and phenylephrine hydrochloride ophthalmic spray) 1%/2.5%
MYDCOMBI is indicated to induce mydriasis
for diagnostic procedures and in conditions where short term pupil dilation is desired
CONTRAINDICATIONS: In patients
with known hypersensitivity to any component of the formulation
WARNINGS AND PRECAUTIONS
Not for Injection: Topical ophthalmic
Significant Elevations in Blood Pressure: Caution
in pediatric patients less than 5 years of age, and in patients with cardiovascular disease or hyperthyroidism. In patients at high risk,
monitor blood pressure post treatment.
Central Nervous System Disturbances: Caution
in pediatric patients where rare incidences of central nervous system disturbances have been reported.
Intraocular Pressure: May produce
a transient elevation
Rebound Miosis: Reported 1 day
after administration
To report SUSPECTED ADVERSE REACTIONS,
contact Eyenovia, Inc. At 1-833-393-6684 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch)
Please go to www.mydcombi.com
for FULL PRESCRIBING INFORMATION
About Eyenovia, Inc.
Eyenovia, Inc. (NASDAQ:
EYEN) is a commercial stage ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics.
Eyenovia is currently focused on the commercialization of Mydcombi for mydriasis, as well as the ongoing late-stage development of medications
in the Optejet device for 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 the statements,
expectations and assumptions contained in this presentation 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, 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 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, legislative and geopolitical 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
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:
Vice President, Commercial Operations