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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:
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Physical requirements such as dimensions and weight, and presence and operation of various light indicators
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Usability requirements identified, including forces required to actuate the device or connect and disconnect the cartridge
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Dosing performance, with consistency in delivering ophthalmic liquids to within a standard deviation of 1 microliter.
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Longevity testing demonstrating that the device can operate without failure for the intended life span and with a sufficient safety factor.
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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.
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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.
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The Optejet UFD has satisfactorily met all requirements.
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“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.