Eyenovia to Present Data on Preservative-Free Microbial Integrity of the Optejet®

Rhea-AI Summary

Eyenovia to present on microbial integrity of Optejet device at American Academy of Optometry’s Annual Meeting

Positive

• Eyenovia's Optejet device demonstrates ability to maintain product sterility even when exposed to high microbial load

Negative

• None.

In rigorous testing, the Optejet remained contaminant-free when subjected to a microbial load that exceeds typical environmental conditions

Presentation to be made at the American Academy of Optometry’s “Academy 2023 New Orleans” Annual Meeting

NEW YORK, Oct. 09, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company commercializing Mydcombi™ for mydriasis, preparing for regulatory approval of APP13007 for relief of pain and inflammation post ocular surgery, and incorporating its advanced Optejet^® device with late-stage product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced that it will deliver a presentation on the microbial integrity of its Optejet dispensing device at the American Academy of Optometry’s “Academy 2023 New Orleans” Annual Meeting, which is being held October 11-14, 2023.

“Recent studies of both preserved and preservative-free multi-use eye drops have shown contamination rates as high as 94%, suggesting that there is an urgent need for a next-generation topical ophthalmic drug dispensing device that can administer medication without preservatives or contaminants, both of which can be harmful to the eye,” stated Michael Rowe, chief executive officer of Eyenovia. “This study successfully demonstrates the Optejet’s ability to maintain product sterility even when exposed to a microbial load that exceeds typical environmental conditions, supporting the potential for the Optejet to be used to deliver preservative-free medications, which would confer significant long-term benefits to patients.”

Presentation details:
Title:	Demonstration of Microbial Integrity for a Multi-Dose Ophthalmic Spray Drug Device
Date:	Thursday, October 12, 2023
Time:	4:30-6:30pm CT (5:30-7:30pm ET)
Location:	Exhibit Hall D, New Orleans Ernest N. Morial Convention Center
Poster #:	36

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.

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

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

FAQ

What is Eyenovia presenting at the American Academy of Optometry's Annual Meeting?

Eyenovia is presenting on the microbial integrity of its Optejet dispensing device.

What are the potential benefits of the Optejet device?

The Optejet device can deliver preservative-free medications, which would provide significant long-term benefits to patients.

When and where will the presentation take place?

The presentation will take place on Thursday, October 12, 2023, from 4:30-6:30pm CT (5:30-7:30pm ET) in Exhibit Hall D of the New Orleans Ernest N. Morial Convention Center.

What did the study demonstrate about the Optejet device?

The study demonstrated that the Optejet device can maintain product sterility even when exposed to a microbial load that exceeds typical environmental conditions.

Why is maintaining product sterility important in ophthalmic drug dispensing?

Maintaining product sterility is important to prevent contamination, which can be harmful to the eye.