Eyenovia Provides Development Update on Optejet User Filled Device (UFD)
Eyenovia (NASDAQ: EYEN) reports significant progress in developing its Optejet User Filled Device (UFD), targeting regulatory submission in Q4 2025. The device, designed for topical ophthalmic liquids including artificial tears and lens rewetting products, has successfully completed key verification and validation studies.
The completed parameters include physical requirements, usability testing, and dosing performance with precision within 1 microliter deviation. Notably, longevity testing demonstrated the device's capability to precisely dispense beyond 30,000 actuations. Safety testing, including electromagnetic interference and compatibility, has met all requirements according to IEC 60601 standards.
The company aims to submit a 510(k) application as early as September 2025, positioning the UFD Optejet to potentially double the usage efficiency of current eyedrop solutions.
Eyenovia (NASDAQ: EYEN) riporta progressi significativi nello sviluppo del suo Dispositivo a Ricarica Utente Optejet (UFD), con l'obiettivo di presentare la domanda di regolamentazione nel quarto trimestre del 2025. Il dispositivo, progettato per liquidi oftalmici topici, tra cui lacrime artificiali e prodotti per la riidratazione delle lenti, ha completato con successo studi chiave di verifica e validazione.
I parametri completati includono requisiti fisici, test di usabilità e prestazioni di dosaggio con una precisione all'interno di 1 microlitro di deviazione. In particolare, i test di longevità hanno dimostrato la capacità del dispositivo di erogare con precisione oltre 30.000 attivazioni. I test di sicurezza, inclusi quelli per l'interferenza elettromagnetica e la compatibilità, hanno soddisfatto tutti i requisiti secondo gli standard IEC 60601.
L'azienda mira a presentare una domanda 510(k) già a settembre 2025, posizionando l'UFD Optejet per potenzialmente raddoppiare l'efficienza d'uso delle attuali soluzioni per gocce oculari.
Eyenovia (NASDAQ: EYEN) informa sobre avances significativos en el desarrollo de su Dispositivo Llenado por el Usuario Optejet (UFD), con el objetivo de presentar una solicitud regulatoria en el cuarto trimestre de 2025. El dispositivo, diseñado para líquidos oftálmicos tópicos, incluidos lágrimas artificiales y productos para rehidratación de lentes, ha completado con éxito estudios clave de verificación y validación.
Los parámetros completados incluyen requisitos físicos, pruebas de usabilidad y rendimiento de dosificación con una precisión dentro de 1 microlitro de desviación. Notablemente, las pruebas de longevidad demostraron la capacidad del dispositivo para dispensar con precisión más de 30,000 activaciones. Las pruebas de seguridad, incluida la interferencia electromagnética y la compatibilidad, han cumplido con todos los requisitos según los estándares IEC 60601.
La empresa tiene como objetivo presentar una solicitud 510(k) tan pronto como en septiembre de 2025, posicionando el UFD Optejet para potencialmente duplicar la eficiencia de uso de las soluciones actuales de gotas para los ojos.
아이노비아 (NASDAQ: EYEN)는 사용자 채우기 장치(Optejet UFD) 개발에서 중요한 진전을 보고하며, 2025년 4분기에 규제 제출을 목표로 하고 있습니다. 이 장치는 인공 눈물 및 렌즈 재습윤 제품을 포함한 국소 안과 액체를 위해 설계되었으며, 주요 검증 및 검증 연구를 성공적으로 완료했습니다.
완료된 매개변수에는 물리적 요구 사항, 사용성 테스트 및 1 마이크로리터 편차 내에서의 정밀한 용량 성능이 포함됩니다. 특히, 내구성 테스트는 장치가 30,000회 작동 이상을 정확하게 분배할 수 있는 능력을 입증했습니다. 전자기 간섭 및 호환성을 포함한 안전성 테스트는 IEC 60601 기준에 따라 모든 요구 사항을 충족했습니다.
회사는 2025년 9월에 510(k) 신청서를 제출할 계획이며, UFD Optejet이 현재의 안약 솔루션의 사용 효율성을 두 배로 늘릴 가능성을 가지고 있습니다.
Eyenovia (NASDAQ: EYEN) fait état de progrès significatifs dans le développement de son Dispositif Rempli par l'Utilisateur Optejet (UFD), visant une soumission réglementaire au quatrième trimestre 2025. Le dispositif, conçu pour les liquides ophtalmiques topiques, y compris les larmes artificielles et les produits de réhydratation des lentilles, a réussi à compléter des études clés de vérification et de validation.
Les paramètres achevés incluent des exigences physiques, des tests d'utilisabilité et des performances de dosage avec une précision de 1 microlitre de déviation. Notamment, les tests de longévité ont démontré la capacité du dispositif à délivrer avec précision plus de 30 000 activations. Les tests de sécurité, y compris l'interférence électromagnétique et la compatibilité, ont satisfait à toutes les exigences selon les normes IEC 60601.
L'entreprise vise à soumettre une demande 510(k) dès septembre 2025, positionnant le UFD Optejet pour potentiellement doubler l'efficacité d'utilisation des solutions actuelles de gouttes oculaires.
Eyenovia (NASDAQ: EYEN) berichtet über bedeutende Fortschritte bei der Entwicklung seines Benutzergefüllten Geräts Optejet (UFD), mit dem Ziel, im vierten Quartal 2025 einen regulatorischen Antrag einzureichen. Das Gerät, das für topische ophthalmische Flüssigkeiten, einschließlich künstlicher Tränen und Produkte zur Benetzung von Kontaktlinsen, entwickelt wurde, hat wichtige Verifizierungs- und Validierungsstudien erfolgreich abgeschlossen.
Die abgeschlossenen Parameter umfassen physikalische Anforderungen, Benutzertests und Dosierleistung mit einer Präzision von innerhalb von 1 Mikroliter Abweichung. Besonders bemerkenswert ist, dass die Langlebigkeitsprüfung die Fähigkeit des Geräts nachwies, präzise über 30.000 Betätigungen hinaus zu dosieren. Sicherheitstests, einschließlich elektromagnetischer Störungen und Kompatibilität, haben alle Anforderungen gemäß den IEC 60601-Standards erfüllt.
Das Unternehmen plant, bereits im September 2025 einen 510(k)-Antrag einzureichen, um das UFD Optejet zu positionieren, das potenziell die Nutzungseffizienz der aktuellen Augentropfenlösungen verdoppeln könnte.
- Successfully completed all verification and validation testing requirements
- Device demonstrates high precision with 1 microliter standard deviation in dosing
- Exceptional durability proven with over 30,000 successful actuations
- Technology potentially doubles efficiency of current eyedrop solutions
- Regulatory approval timeline extends to Q4 2025, indicating a significant wait before potential commercialization
Insights
Eyenovia's development update on its Optejet UFD demonstrates significant technical progress toward their regulatory filing. The completed V&V study parameters cover critical aspects regulators focus on: physical specifications, usability, dosing precision, durability, and safety testing compliance. The dosing consistency with just 1 microliter standard deviation is particularly noteworthy for ophthalmic applications where precise medication delivery is crucial.
From a regulatory perspective, the targeted 510(k) pathway is strategically sound for this device category, offering a more streamlined approval process than PMA alternatives. Their timeline for submission in Q4 2025 with CEO suggesting potentially as early as September appears realistic given the comprehensive testing completed thus far. The company has addressed electromagnetic interference compliance and electrostatic discharge testing—often overlooked components that frequently cause regulatory delays.
The longevity testing demonstrating functionality beyond 30,000 actuations exceeds typical requirements and suggests robust engineering that should support favorable regulatory review. While progress appears on track, investors should recognize that 510(k) clearance, though generally more predictable than other pathways, still carries inherent uncertainty in timing and outcome.
This development update positions Eyenovia to potentially disrupt multiple billion-dollar markets in artificial tears and lens rewetting solutions. The key differentiator for their Optejet UFD is the user-filled capability combined with precision dosing technology, addressing a fundamental inefficiency in traditional eyedroppers where substantial medication is wasted.
The claim that consumers could obtain twice as many uses from their current eyedrops represents a compelling value proposition in a market where consumers are increasingly cost-conscious. Beyond efficiency, the precision dosing (consistent delivery within 1 microliter) addresses the common patient complaint of inconsistent drop sizes with conventional products.
Strategically, entering the over-the-counter eyecare market with this platform technology creates multiple revenue opportunities while potentially building brand recognition that could benefit their prescription medication pipeline. The artificial tears segment alone represents a $2.5+ billion market growing at approximately 5-7% annually, driven by increasing screen time, aging demographics, and rising dry eye prevalence.
While the technology appears promising, Eyenovia faces the challenge of convincing consumers to adopt a new delivery mechanism in a traditionally conservative market. Their success will depend on pricing strategy, distribution partnerships, and effectively communicating the economic and therapeutic advantages of their precision platform.
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,
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
FAQ
When will Eyenovia (EYEN) submit the Optejet UFD for regulatory approval?
How many actuations can the Optejet UFD device perform?
What is the dosing precision of Eyenovia's Optejet UFD device?
What types of eye products can be used with the Optejet UFD?
