News Release

Course to provide ophthalmic technicians with background on the Optejet dispensing technology and training on the use of Mydcombi™ for mydriasis

NEW YORK, Oct. 30, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company commercializing Mydcombi™ for mydriasis, preparing for regulatory approval of APP130007 for relief of pain and inflammation post ocular surgery, and incorporating its advanced 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 it is sponsoring a course during the International Joint Commission on Allied Health Personnel in Ophthalmology (IJCAHPO) 51^st Annual Continuing Education (ACE) program, which is being held November 3-5 in San Francisco.

The course, Topical Pharmaceutical Drug Delivery Innovations: The Potential Role for the New Ophthalmic Spray, will offer ophthalmic technicians background on Eyenovia’s Optejet dispensing technology and training on the use of Mydcombi in daily practice.

“As the first FDA-approved mydriasis agent to combine tropicamide and phenylephrine, and the first product to leverage the Optejet device, we believe Mydcombi represents a true advancement for eye care practitioners and their technicians, and we are pleased to sponsor this course at IJCAHPO’s ACE program to raise awareness of the technology and provide training on its use,” stated Michael Rowe, chief executive officer of Eyenovia. “We continue to ramp our internal manufacturing capabilities, staff our sales management team and obtain additional key state licenses of which we now have eight either completed or in process. We look forward to transitioning to a broader commercial launch of Mydcombi in early 2024.”

The Optejet dispensing technology used for Mydcombi was recently the subject of a presentation at the American Academy of Optometry and Mydcombi will be the main focus of the Eyenovia booth at the American Academy of Ophthalmology convention on November 4-6 in San Francisco. In addition, Mydcombi was featured in a white paper on Touch Ophthalmology, Pharmacologic Mydriasis and Cycloplegia: A Review of Novel Delivery Devices, which can be accessed here.

PLEASE GO TO MYDCOMBI.COM FOR IMPORTANT SAFETY INFORMATION for MYDCOMBI™ (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5%

About Eyenovia, Inc.
Eyenovia, Inc. (NASDAQ: EYEN) is a commercial-stage ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics based on its Optejet platform. Eyenovia is currently focused on the commercialization of Mydcombi (tropicamide+phenylephrine ophthalmic spray) for mydriasis.

In addition to commercializing Mydcombi, in August 2023, Eyenovia acquired the U.S. commercial rights to APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%) from Formosa Pharmaceuticals. APP13007, which is currently under review by the FDA, is a potent steroid being developed to reduce pain and inflammation following ocular surgery. The agency has assigned a Prescription Drug User Fee Act (PDUFA) action date for APP13007 of March 4, 2024.

Eyenovia is also advancing late-stage development of medications in the Optejet device for presbyopia and myopia progression (partnered with Bausch+Lomb in the U.S. and Canada and Arctic Vision in China and South Korea).

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 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, and the potential for approval of APP13007. 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 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.

Eyenovia Contact:
Eyenovia, Inc.
John Gandolfo
Chief Financial Officer
jgandolfo@eyenovia.com

Eyenovia Investor Contact:
Eric Ribner
LifeSci Advisors, LLC
eric@lifesciadvisors.com
(646) 751-4363

Eyenovia Media Contact:
Eyenovia, Inc.
Norbert Lowe
Vice President, Commercial Operations
nlowe@eyenovia.com

Source: Eyenovia, Inc.