Eyenovia Announces Launch and Commercial Availability of Clobetasol Propionate Ophthalmic Suspension 0.05% for Post-Operative Inflammation and Pain Following Ocular Surgery

NEW YORK, Sept. 26, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic technology company, today announced the U.S. launch and commercial availability of clobetasol propionate ophthalmic suspension 0.05% ("Clobetasol"), approved by the FDA for the treatment of post-operative inflammation and pain following ocular surgery.

"The commercial launch of Clobetasol represents a significant milestone for our company, and as the first new ophthalmic steroid to be approved in more than 15 years, a meaningful advancement in the field of ocular surgery," stated Michael Rowe, Chief Executive Officer of Eyenovia. "With its efficacy and safety profile, convenient twice-a-day dosing regimen, and streamlined distribution that is designed to eliminate complications from insurance, we believe Clobetasol will generate strong interest among eye doctors."

Dr. Erick Co, President & CEO of Formosa Pharma, said, "This commercial U.S. launch of clobetasol has been much anticipated and we are excited to provide this formidable therapy to ocular surgery patients in the U.S. with our partner, Eyenovia. We also look forward to further collaborating with Eyenovia to develop Clobetasol as a treatment for dry eye utilizing its Optejet^® platform technology."

Eyenovia also announced the results of its recently commissioned market research indicating a strong level of interest from ophthalmic surgeons in Clobetasol based upon their review of its prescribing information.¹ Key highlights from the survey include:

• Of the 100 ophthalmic surgeons surveyed, respondents ranked efficacy as the most important characteristic of a post-operative steroid. In clinical studies of Clobetasol, approximately 80% of patients had complete relief from pain as soon as four days post-surgery (versus approximately 50% for patients who had vehicle)
• The safety information specific to clobetasol was also of importance with clinical study results showing no single adverse event affected more than 2% of patients
• Managed care hurdles were cited by 53% of respondents as the most significant issue with prescribing ophthalmic steroids. Knowing that Clobetasol will be made available to patients at a low fixed price regardless of their insurance status was seen by surgeons as a positive way to eliminate insurance complications that burden office staff
• Based solely on a review of the approved label and the way it will be distributed, the majority of respondents indicated a high level of interest in prescribing Clobetasol

About Eyenovia, Inc.

Eyenovia, Inc. (NASDAQ:EYEN) is an ophthalmic technology company developing a pipeline of microdose array print therapeutics based on its Optejet^® platform technology. Eyenovia is currently focused on the commercialization of MYDCOMBI^® for mydriasis, clobetasol propionate ophthalmic suspension, 0.05% for post-operative inflammation and pain following ocular surgery, 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 estimated market opportunities for our product candidates and platform technology, and the timing for availability and sales growth 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.

Eyenovia Contact:

Eyenovia, Inc.

Andy Jones

Chief Financial Officer

[email protected]

Eyenovia Investor Contact:

Eric Ribner

LifeSci Advisors, LLC

[email protected]

(646) 751-4363

Eyenovia Media Contact:

Eyenovia, Inc.

Norbert Lowe

Vice President, Commercial Operations

[email protected]

¹ Data on File