On track for regulatory submission seeking marketing approval of the Optejet UFD in Q4 2025
NEW YORK, April 10, 2025 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN) (“Eyenovia” or the “Company”), an ophthalmic technology company developing and commercializing advanced products leveraging its proprietary Optejet topical ophthalmic medication dispensing platform, today provided an update on recent progress made in the development of the Company’s novel Optejet UFD. The user-filled Optejet is designed to work with a variety of topical ophthalmic liquids, including artificial tears and lens rewetting products, spanning multiple billion-dollar markets.
Eyenovia continues to advance the Optejet UFD through Verification & Validation (V&V) studies to ensure that the device meets the standards around intended use and customer requirements. As of today, the Company has completed the following parameters:
- Physical requirements such as dimensions and weight, and presence and operation of various light indicators
- Usability requirements identified, including forces required to actuate the device or connect and disconnect the cartridge
- Dosing performance, with consistency in delivering ophthalmic liquids to within a standard deviation of 1 microliter.
- Longevity testing demonstrating that the device can operate without failure for the intended life span and with a sufficient safety factor.
- In particular, tested key components more than 30,000 times, and demonstrated that the device can precisely dispense the ophthalmic solution well beyond 30,000 actuations.
- Safety testing of the base according to recognized standards, such as IEC 60601, to ensure performance specifications are met. This testing includes, among other things, electromagnetic interference, compatibility, and electrostatic discharge testing.
- The Optejet UFD has satisfactorily met all requirements.
- The Optejet UFD has satisfactorily met all requirements.
“The user-filled Optejet device is well on its way towards registration,” stated Michael Rowe, Chief Executive Officer of Eyenovia. “The combination of the UFD Optejet with an artificial tear or lens rewetting solution may significantly enhance the user experience while allowing many consumers to obtain twice as many uses from their current eyedrops. We look forward to completing the remaining V&V studies and preparing for a 510(k) submission as early as September of this year.”
About Eyenovia, Inc.
Eyenovia, Inc. is an ophthalmic technology company developing and commercializing advanced products leveraging its proprietary Optejet topical ophthalmic medication dispensing platform. The Optejet is especially useful in chronic front-of-the-eye diseases due to its ease of use, enhanced safety and tolerability, and potential for superior compliance versus standard eye drops. Together, these benefits may combine to produce better treatment options and outcomes for patients and providers. The company’s current commercial portfolio includes clobetasol propionate ophthalmic suspension, 0.05%, for post-surgical pain and inflammation, and Mydcombi® for mydriasis. 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, our future activities or other future events or conditions, including those relating to the completion of due diligence on and a definitive transaction agreement in conjunction with our strategic processes, the estimated market opportunities for our 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: the risk that any proposed transactions do not proceed; risks of our clinical trials, including, but not limited to, the potential advantages of our products, and platform technology; the rate and degree of market acceptance and clinical utility of our products; our estimates regarding the potential market opportunity for our products; reliance on third parties to develop and commercialize our products; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies for our products; 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; our competitive position; and our ability to raise additional funds to maintain our business operations and to make payments on our debt obligations as and when necessary.
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.
Norbert Lowe
Vice President, Commercial Operations
nlowe@eyenovia.com
Eyenovia Investor Contact:
Eric Ribner
LifeSci Advisors, LLC
eric@lifesciadvisors.com
(646) 751-4363
