Full Press Release Details
Eyenovia Reports Second Quarter 2023 Financial
Results and Provides Business Update
Announced FDA approval of and first commercial
sale of Mydcombi , the only fixed dose combination of tropicamide and phenylephrine for mydriasis and the first FDA approved product
to utilize the Optejet
Continued to advance its Phase 3 Apersure
(Microline) presbyopia candidate following receipt of guidance from FDA that establishes an efficient path forward for the program
Company to host conference call and webcast
today, August 10, at 4:30 pm ET
NEW YORK-August 10, 2023-Eyenovia,
Inc. (NASDAQ: EYEN), an ophthalmic technology company commercializing Mydcombi (tropicamide+phenylephrine ophthalmic spray) for
mydriasis and 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 its financial and operating
results for the second quarter ended June 30, 2023.
Second Quarter 2023 and Recent Business Developments
Michael Rowe, Chief Executive Officer, commented,
"We achieved very significant milestones since our last quarterly update, notably the FDA approval and first commercial sale of
Mydcombi, officially transitioning us to a commercial stage company. We are now executing a targeted launch of Mydcombi while in parallel
ramping up our internal manufacturing capabilities in anticipation of a broader campaign incorporating our Gen 2 Optejet device beginning
"Regarding our pre-NDA presbyopia candidate,
Apersure, we continue to advance this important program following receipt of feedback from FDA that established a clear and efficient
path forward. The addressable presbyopia market for topical ophthalmic medications is a nearly one-billion-dollar market opportunity in
the US alone, and we believe an effective solution that leverages our novel Optejet drug delivery platform and fits within the business
model of optometrists will be highly differentiated in the marketplace. We plan to initiate the manufacture of registration batches of
Apersure during the fourth quarter.
"We believe the approval and commercial
availability of Mydcombi will fundamentally transform the way that topical eye drugs are developed and delivered, as we now have critical
validation of our Optejet platform that will benefit not only our proprietary development programs, most notably Apersure, but current
and future partnerships as well. To that end, we continue to have very productive discussions with potential partners that could ultimately
see the Optejet incorporated into additional large market ophthalmology indications with persistent unmet needs.
"I am extremely pleased with our progress
to date and look forward to a productive back half of the year," Mr. Rowe concluded.
Second Quarter 2023 Financial Review
For the second quarter of 2023, net loss was approximately
$(6.2) million, or $(0.16) per share compared to a net loss of approximately $(7.2) million, or $(0.22) per share, for the second quarter
Research and development expenses totaled approximately
$2.8 million for the second quarter of 2023 as compared to $3.6 million for the second quarter of 2022.
For the second quarter of 2023, general and administrative
expenses were approximately $3.1 million, compared to $3.5 million for the second quarter of 2022.
Total operating expenses for the second quarter
of 2023 were approximately $6.0 million compared to $7.1 million for the second quarter of 2022.
As of June 30, 2023, the Company's cash
and cash equivalents were approximately $17.5 million compared to $22.9 million as of December 31, 2022.
Conference Call and Webcast
The conference call is scheduled to begin at 4:30
pm ET today, August 10. Participants should dial 1-877-407-9039 (domestic) or 1-201-689-8470 (international), and reference conference
To access the Call me feature, which avoids
having to wait for an operator, click here.
A live webcast of the conference call will also
be available on the investor relations page of the Company's corporate website at www.eyenovia.com. After the live webcast, the
event will be archived on Eyenovia's website for one year.
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
FOR TOPICAL OPHTHALMIC
USE. NOT FOR INJECTION
This preparation may
cause CNS disturbances which may be dangerous in pediatric patients. The possibility of psychotic reaction and behavioral disturbance
due to hypersensitivity to anticholinergic drugs should be considered.
Mydriatics may produce
a transient elevation of intraocular pressure.
Significant elevations
in blood pressure have been reported. Caution in patients with elevated blood pressure.
Rebound miosis has been
reported one day after installation.
Remove contact lenses
Atropine-like Drugs:
May exaggerate the adrenergic pressor response
Cholinergic Agonists
and Ophthalmic Cholinesterase Inhibitors: May interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic
cholinesterase inhibitors
Anesthetic Agents: May potentiate cardiovascular depressant effects of some inhalation anesthetic agents
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 an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics. Eyenovia is
currently focused on the commercialization of Mydcombi and the late-stage development of microdosed medications for presbyopia and myopia
progression. For more information, visit www.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 products, 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. 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 impacts of any disruptions on our supply
chain, including the availability of sufficient components and materials used in our products and product candidates; the potential advantages