Eyenovia Announces Presentation of Phase 3 Clobetasol Study Results at the American Academy of Ophthalmology (AAO) 2024 Expo

Presentation details efficacy and tolerability results from the successful Phase 3 program that led to FDA approval of clobetasol propionate suspension 0.05% for pain and inflammation following ocular surgery

NEW YORK, Oct. 16, 2024 (GLOBE NEWSWIRE) — Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company, today announced a presentation at the American Academy of Ophthalmology (AAO) 2024 Expo, which is being held October 19-21, in Chicago.

The presentation will detail the results of a successful Phase 3 study (CPN-302) of clobetasol propionate suspension 0.05% (APP13007) that led to its approval by the U.S. Food and Drug Administration as a treatment for inflammation and pain following ocular surgery. Eyenovia announced the U.S. launch and commercial availability of clobetasol on September 26, 2024.

“We are very pleased to see the results from this successful Phase 3 study of clobetasol presented at this year’s AAO Expo,” stated Michael Rowe, Chief Executive Officer of Eyenovia. “The results demonstrated the magnitude and speed of inflammation and pain relief as soon as four days post-surgery as compared to placebo, with a more rapid improvement in visual acuity and a desirable safety profile.”

“Clobetasol is now available through our pharmacy partner, Medvantx, or directly through EyenoviaRx.com. With its convenient twice-per-day dosing regimen and a distribution model that minimizes hassles for prescribers, we believe clobetasol is poised to quickly become a preferred post-operative steroid by physicians and patients alike,” Mr. Rowe concluded.

For additional information on the AAO 2024 Expo: https://www.aao.org/annual-meeting

About Eyenovia, Inc.

Eyenovia, Inc. (NASDAQ: EYEN) is an ophthalmic technology company developing a pipeline of advanced products based on its Optejet platform. Eyenovia is currently focused on the commercialization of Mydcombi^® for mydriasis, clobetasol propionate ophthalmic suspension, 0.05% for post-surgical pain and inflammation, as well as the ongoing late-stage development of medications in the Optejet device for pediatric progressive myopia as well as out-licensing for additional indications. 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%

PLEASE GO TO CLOBETASOLBID.COM FOR IMPORTANT SAFETY INFORMATION for Clobetasol Propionate Ophthalmic Suspension 0.05%

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 the timing and scale of acceptance and use of our approved products. 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 products and product candidates; the potential advantages of our products, product candidates and platform technology; the rate and degree of market acceptance and clinical utility of our products and product candidates; our estimates regarding the potential market opportunity for our products and product candidates; reliance on third parties to develop and commercialize our products and product candidates; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies for our products and 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 product candidates; 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.