Tropicamide

NEW YORK, Sept. 27, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN) (“Eyenovia” or the “Company”), an ophthalmic technology company with two FDA-approved products and a late-stage asset in development for the treatment of pediatric progressive myopia, today announced it has entered into a securities purchase agreement with a healthcare focused institutional investor for the purchase and sale of 8,695,653 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to an aggregate of 8,695,653 shares of common stock in a registered direct offering at a combined offering price of $0.46 per share and accompanying warrant. The warrants have an exercise price of $0.50 per share, will be exercisable commencing six months from the date of issuance and will expire five years from the initial exercise date. The closing of the offering is expected to take place on or about September 30, 2024, subject to the satisfaction of customary closing conditions. The gross proceeds of the offering will be approximately $4 million before deducting placement agent fees and other estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering to fund commercialization activities for Mydcombi and clobetasol propionate, complete the CHAPERONE pediatric myopia clinical study, and for working capital and general corporate purposes, which may include the repayment of a portion of existing indebtedness. A.G.P./Alliance Global Partners is acting as the lead placement agent for the offering and Brookline Capital Markets, a division of Arcadia Securities, LLC is acting as a co-placement agent for the offering. The securities described above are being offered by Eyenovia pursuant to its previously filed shelf registration statement on Form S-3, which was declared effective by the Securities and Exchange Commission (the “SEC”) on December 23, 2021. The offering may be made only by means of a base prospectus and accompanying prospectus supplement. A prospectus supplement relating to the offering will be filed with the SEC and, once filed, will be available on the SEC’s website at www.sec.gov. Additionally, when available, electronic copies of the prospectus supplement may be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at prospectus@allianceg.com. This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. About Eyenovia, Inc. Eyenovia, Inc. is an ophthalmic technology company commercializing Mydcombi™ (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for mydriasis, Clobetasol Propionate Ophthalmic Suspension, 0.05% for postsurgical inflammation and pain, and developing the Optejet® device for use both in connection with its own drug-device therapeutic product for pediatric progressive myopia as well as out-licensing for additional indications. For more information, please visit Eyenovia.com. 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 those relating to the offering, the closing of the offering, the amount and anticipated use of proceeds from the offering, estimated market opportunities for our product candidates and platform technology, the timing for sales growth of our approved products, and the outcome of the process to explore strategic alternatives to maximize shareholder value. 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 JonesChief Financial Officerajones@eyenovia.com Eyenovia Investor Contact:Eric RibnerLifeSci Advisors, LLCeric@lifesciadvisors.com(646) 751-4363 Eyenovia Media Contact:Eyenovia, Inc.Norbert LoweVice President, Commercial Operationsnlowe@eyenovia.com

New market research shows strong interest from ophthalmic surgeons following their review of Clobetasol’s prescribing informationNEW 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 patientsManaged 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 staffBased 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 StatementsExcept 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 Officerajones@eyenovia.com Eyenovia Investor Contact:Eric RibnerLifeSci Advisors, LLCeric@lifesciadvisors.com(646) 751-4363 Eyenovia Media Contact:Eyenovia, Inc.Norbert LoweVice President, Commercial Operationsnlowe@eyenovia.com 1 Data on File