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

EYEN 10.16.2024

Full Press ReleaseSEC FilingsOur EYEN Tweets

About Gravity Analytica

Recent News

  • 01.15.2025 - Eyenovia Announces Leading Proxy Advisory Firms, ISS and Glass Lewis, Recommend Eyenovia Stockholders Vote “FOR” Proposed Reverse Stock Split at Upcoming Special Meeting of Stockholders
  • 01.06.2025 - Eyenovia Engages Chardan as Advisor for Review of Strategic Alternatives
  • 12.06.2024 - Eyenovia, Inc. Announces Pricing of $1.9 Million Registered Direct Offering

Recent Filings

  • 01.16.2025 - 424B3 Prospectus [Rule 424(b)(3)]
  • 01.16.2025 - 8-K Current report
  • 01.15.2025 - DEFA14A Additional definitive proxy soliciting materials and Rule 14(a)(12) material
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 theAmerican Academy of Ophthalmology(AAO) 2024 Expo, which is being heldOctober 19-21, inChicago.

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 theU.S. Food and Drug Administrationas a treatment for inflammation and pain following ocular surgery.Eyenoviaannounced theU.S.launch and commercial availability of clobetasol onSeptember 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,” statedMichael Rowe, Chief Executive Officer ofEyenovia. “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 throughEyenoviaRx.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. Roweconcluded.

Presentation details:
Title:Clobetasol Propionate Ophthalmic Suspension 0.05% (APP 13007) for the Treatment of Postsurgical Inflammation and Pain (Study CPN-302)
Presenter:Jeffrey H Levenson MD,Levenson Eye Associates
Date/time:Available on-demand throughout the AAO Expo

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

AboutEyenovia, Inc.

Eyenovia, Inc.(NASDAQ: EYEN) is an ophthalmic technology company developing a pipeline of advanced products based on its Optejet platform.Eyenoviais 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, visitEyenovia.com.

The Eyenovia Corporate Information slide deck may be found atir.eyenovia.com/events-and-presentations.

PLEASE GO TOMYDCOMBI.COMFOR IMPORTANT SAFETY INFORMATION for MYDCOMBITM (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5%

PLEASE GO TOCLOBETASOLBID.COMFOR 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.

Eyenovia Contact:Eyenovia, Inc.Andy JonesChief Financial Officerajones@eyenovia.comEyenovia Investor Contact:Eric RibnerLifeSci Advisors, LLCeric@lifesciadvisors.com(646) 751-4363Eyenovia Media Contact:Eyenovia, Inc.Norbert LoweVice President, Commercial Operationsnlowe@eyenovia.com

Primary Logo

Source: Eyenovia, Inc.

Please be aware that the following content has been generated by an AI system and may contain errors, inconsistencies, or outdated information. It is provided as-is without any warranties or guarantees of accuracy. We strongly recommend using this content as a starting point for further research and consultation with relevant experts or authorities. We disclaim any liability for damages or losses resulting from the use or reliance on this content.Please note that this is a beta version of the Gravity Analytica LLC’s AI Service which isstill undergoing final testing before its official release. Theplatform, its software and all content found on it are provided on an“as is” and “as available” basis. Gravity Analytica LLC does not give any warranties,whether express or implied, as to the suitability or usability of thisservice, webpage, or its software or any of its content.Should you encounter any bugs, glitches, lack of functionality orother problems on the website, please let us know immediately so wecan rectify these accordingly. Your help in this regard is greatlyappreciated! You can write to us at this addressteam@gravityanalytica.com