Eyenovia Announces Commencement of Manufacturing of its Advanced, Second Generation Optejet Device
Eyenovia, Inc. (NASDAQ: EYEN) has begun manufacturing registration batches of its FDA-approved mydriasis product, Mydcombi, using the advanced Gen-2 Optejet dispensing platform. This marks a important step in the approval process for the new device, which is designed for an optimized user experience and extended patent protection through 2041.
The Gen-2 Optejet features improvements such as one-button use and compatibility with Eyenovia's digital compliance monitoring program, Optecare™. The company received feedback from the FDA in July that aligned with their device qualification plan, allowing for efficient progress in manufacturing and testing.
Eyenovia expects to complete testing of Mydcombi registration batches by the end of next year, with a potential SNDA filing in early 2026. The Gen-2 Optejet platform may also provide lower manufacturing costs and streamline future regulatory interactions for additional therapeutics, including those in development partnerships.
Eyenovia, Inc. (NASDAQ: EYEN) ha iniziato a produrre lotti di registrazione del suo prodotto approvato dalla FDA per la midriasi, Mydcombi, utilizzando l'avanzata piattaforma di dispensazione Gen-2 Optejet. Questo segna un passo importante nel processo di approvazione del nuovo dispositivo, progettato per un'esperienza utente ottimizzata e una protezione del brevetto estesa fino al 2041.
La Gen-2 Optejet presenta miglioramenti come l'uso con un pulsante e la compatibilità con il programma di monitoraggio della conformità digitale di Eyenovia, Optecare™. L'azienda ha ricevuto un feedback dalla FDA a luglio che si allineava con il loro piano di qualifica del dispositivo, consentendo un progresso efficiente nella produzione e nei test.
Eyenovia prevede di completare i test dei lotti di registrazione di Mydcombi entro la fine del prossimo anno, con una possibile presentazione SNDA all'inizio del 2026. La piattaforma Gen-2 Optejet potrebbe anche offrire costi di produzione inferiori e semplificare le interazioni regolatorie future per ulteriori terapie, inclusi quelli in partenariati di sviluppo.
Eyenovia, Inc. (NASDAQ: EYEN) ha comenzado a fabricar lotes de registro de su producto aprobado por la FDA para la midriasis, Mydcombi, utilizando la avanzada plataforma de dispensación Gen-2 Optejet. Esto marca un paso importante en el proceso de aprobación del nuevo dispositivo, diseñado para una experiencia de usuario optimizada y una protección de patente extendida hasta 2041.
La Gen-2 Optejet presenta mejoras como uso de un solo botón y compatibilidad con el programa de monitoreo de cumplimiento digital de Eyenovia, Optecare™. La empresa recibió retroalimentación de la FDA en julio que se alineaba con su plan de calificación del dispositivo, lo que permitió un progreso eficiente en la fabricación y las pruebas.
Eyenovia espera completar las pruebas de los lotes de registro de Mydcombi para finales del próximo año, con una potencial presentación SNDA a principios de 2026. La plataforma Gen-2 Optejet también podría ofrecer costos de fabricación más bajos y simplificar futuras interacciones regulatorias para terapias adicionales, incluidas aquellas en asociaciones de desarrollo.
Eyenovia, Inc. (NASDAQ: EYEN)는 FDA 승인을 받은 동공확대 제품 Mydcombi의 등록 배치를 고급 Gen-2 Optejet 배포 플랫폼을 사용하여 제조하기 시작했습니다. 이는 최적화된 사용자 경험과 2041년까지 연장된 특허 보호를 위해 설계된 새로운 장치의 승인 프로세스에서 중요한 단계입니다.
Gen-2 Optejet는 버튼 하나로 사용할 수 있는 기능과 Eyenovia의 디지털 준수 모니터링 프로그램인 Optecare™와의 호환성과 같은 개선 사항을 특징으로 합니다. 이 회사는 7월에 FDA로부터 장치 자격 계획에 부합하는 피드백을 받아 제조 및 테스트에서 효율적인 진행을 가능하게 했습니다.
Eyenovia는 내년 말까지 Mydcombi 등록 배치의 테스트를 완료할 것으로 예상하며, 잠재적인 2026년 초 SNDA 제출이 있을 수 있습니다. Gen-2 Optejet 플랫폼은 또한 더 낮은 제조 비용을 제공하고 추가 치료제에 대한 미래 규제 상호작용을 간소화할 수 있습니다. 이에는 개발 파트너십에서의 제품도 포함됩니다.
Eyenovia, Inc. (NASDAQ: EYEN) a commencé à fabriquer des lots de registration de son produit approuvé par la FDA pour la mydriase, Mydcombi, en utilisant la plateforme de distribution avancée Gen-2 Optejet. Cela représente une étape importante dans le processus d'approbation du nouvel appareil, conçu pour une expérience utilisateur optimisée et une protection par brevet étendue jusqu'en 2041.
La Gen-2 Optejet présente des améliorations telles que l'utilisation à bouton unique et la compatibilité avec le programme de suivi de conformité numérique d'Eyenovia, Optecare™. L'entreprise a reçu des retours de la FDA en juillet qui s'alignaient avec leur plan de qualification de dispositif, permettant un progrès efficace dans la fabrication et les tests.
Eyenovia s'attend à terminer les tests des lots de registration de Mydcombi d'ici la fin de l'année prochaine, avec un potentiel dossier SNDA au début de 2026. La plateforme Gen-2 Optejet pourrait également offrir des coûts de fabrication réduits et rationaliser les interactions réglementaires futures pour d'autres thérapeutiques, y compris celles en partenariats de développement.
Eyenovia, Inc. (NASDAQ: EYEN) hat mit der Herstellung von Registrierungsbatches seines von der FDA genehmigten Mydriasis-Produkts Mydcombi begonnen, unter Verwendung der fortschrittlichen Gen-2 Optejet-Abgabetechnologie. Dies markiert einen wichtigen Schritt im Genehmigungsprozess für das neue Gerät, das für ein optimiertes Benutzererlebnis und einen erweiterten Patentschutz bis 2041 konzipiert wurde.
Die Gen-2 Optejet verfügt über Verbesserungen wie Einsatz mit einem Knopf und Kompatibilität mit Eyenvias digitalem Compliance-Überwachungsprogramm Optecare™. Das Unternehmen erhielt im Juli Feedback von der FDA, das mit ihrem Gerätequalifizierungsplan übereinstimmte, was einen effizienten Fortschritt in der Herstellung und den Tests ermöglichte.
Eyenovia erwartet, die Tests der Mydcombi-Registrierungsbatches bis Ende nächsten Jahres abzuschließen, mit einer potenziellen SNDA-Einreichung zu Beginn des Jahres 2026. Die Gen-2 Optejet-Plattform könnte auch niedrigere Herstellungskosten bieten und zukünftige regulatorische Interaktionen für weitere Therapeutika, einschließlich solcher in Entwicklungskooperationen, vereinfachen.
- Commencement of manufacturing registration batches for Mydcombi using Gen-2 Optejet platform
- FDA feedback aligns with company's device qualification plan
- Gen-2 Optejet offers improved user experience and extended patent protection through 2041
- Potential for lower manufacturing costs and streamlined regulatory interactions for future therapeutics
- SNDA filing for Mydcombi not expected until early 2026
- 12-month stability testing required before potential approval
Insights
The commencement of manufacturing registration batches for Mydcombi using the Gen-2 Optejet device marks a significant milestone for Eyenovia. This advanced platform offers several key advantages:
- Improved user experience with one-button operation
- Integration with Optecare™ digital compliance monitoring
- Potential for lower manufacturing costs
- Extended patent protection until 2041
These enhancements could lead to better patient adherence and potentially increased market share. However, the timeline for potential market impact is extended, with SNDA filing not expected until early 2026. This long development cycle is typical in the medical device industry but may test investor patience.
The FDA's alignment with Eyenovia's qualification plan is a positive sign, potentially reducing regulatory hurdles. The company's strategy to leverage this platform across multiple therapeutics, including partnerships in dry eye treatment, demonstrates a forward-thinking approach to maximize the technology's value.
The Gen-2 Optejet is designed for an optimized user experience while ensuring extended patent protection for products using the platform through 2041
NEW YORK, Oct. 01, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company, today announced that the Company has commenced manufacturing of registration batches of its FDA-approved mydriasis product, Mydcombi, a key step in the approval process for its state-of-the-art Gen-2 Optejet dispensing platform.
Mydcombi will undergo 12-month stability testing and other functional testing in the Gen-2 Optejet device that is consistent with feedback from the Type-C meeting on Eyenovia’s device qualification plan that the Company received from the FDA in July.
“We were very pleased to have received feedback from the FDA that was very consistent with our Gen-2 qualification plan, allowing us to move forward with manufacturing and testing as quickly and efficiently as possible,” stated Michael Rowe, Chief Executive Officer of Eyenovia. “With advances from the prior generation product, including one-button use and compatibility with our digital compliance monitoring program, Optecare™, we view the introduction of the Gen-2 Optejet as a significant upcoming inflection point for our company.”
“Importantly, the work that we are doing for Mydcombi in the Gen-2 Optejet device may also provide significantly lower manufacturing costs and streamline future regulatory interactions as we expand the Gen-2 platform to additional therapeutics, both within our own pipeline as well as those in development partnerships, such as dry eye,” Mr. Rowe concluded.
Eyenovia anticipates completion of testing of its Mydcombi registration batches by the end of next year, with a potential SNDA filing in early 2026.
About Eyenovia, Inc.
Eyenovia, Inc. (NASDAQ: EYEN) is an ophthalmic technology company developing a pipeline of advanced products based on its Optejet platform. Eyenovia is currently focused on the commercialization of Mydcombi® for mydriasis, clobetasol propionate ophthalmic suspension,
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)
PLEASE GO TO CLOBETASOLBID.COM FOR IMPORTANT SAFETY INFORMATION for 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 relating to our future activities or other future events or conditions, including estimated market opportunities for our product candidates and platform technology, the impact of the Gen-2 Optejet device, 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 Officer ajones@eyenovia.com | Eyenovia Investor Contact: Eric Ribner LifeSci Advisors, LLC eric@lifesciadvisors.com (646) 751-4363 | Eyenovia Media Contact: Eyenovia, Inc. Norbert Lowe Vice President, Commercial Operations nlowe@eyenovia.com |
FAQ
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