Eyenovia Announces Presentation of Phase 3 Clobetasol Study Results at the American Academy of Ophthalmology (AAO) 2024 Expo
Eyenovia, Inc. (NASDAQ: EYEN) announced a presentation at the American Academy of Ophthalmology (AAO) 2024 Expo, showcasing results from their successful Phase 3 study (CPN-302) of clobetasol propionate suspension 0.05%. This study led to FDA approval for treating inflammation and pain after ocular surgery. The presentation will highlight the drug's efficacy in providing rapid relief from inflammation and pain, with improvements visible as early as four days post-surgery compared to placebo. It also demonstrated faster visual acuity improvement and a favorable safety profile.
Eyenovia launched clobetasol commercially on September 26, 2024. The drug is available through their pharmacy partner, Medvantx, or directly via EyenoviaRx.com. With its convenient twice-daily dosing and streamlined distribution model, Eyenovia believes clobetasol will quickly become a preferred post-operative steroid among physicians and patients.
Eyenovia, Inc. (NASDAQ: EYEN) ha annunciato una presentazione all'Expo 2024 dell'American Academy of Ophthalmology (AAO), mostrando i risultati del loro riuscito studio di Fase 3 (CPN-302) sulla sospensione di clobetasolo propionato 0,05%. Questo studio ha portato all'approvazione della FDA per il trattamento dell'infiammazione e del dolore dopo un intervento oculare. La presentazione metterà in evidenza l'efficacia del farmaco nel fornire un rapido sollievo dall'infiammazione e dal dolore, con miglioramenti visibili già a quattro giorni dopo l'intervento rispetto al placebo. Ha anche dimostrato un miglioramento più rapido dell'acuità visiva e un profilo di sicurezza favorevole.
Eyenovia ha lanciato clobetasolo commercialmente il 26 settembre 2024. Il farmaco è disponibile tramite il loro partner farmaceutico, Medvantx, o direttamente su EyenoviaRx.com. Con il suo comodo dosaggio due volte al giorno e un modello di distribuzione semplificato, Eyenovia crede che il clobetasolo diventerà rapidamente uno steroide post-operatorio preferito tra i medici e i pazienti.
Eyenovia, Inc. (NASDAQ: EYEN) anunció una presentación en el Expo 2024 de la American Academy of Ophthalmology (AAO), mostrando los resultados de su exitoso estudio de Fase 3 (CPN-302) sobre suspensión de clobetasol propionato al 0,05%. Este estudio llevó a la aprobación de la FDA para el tratamiento de la inflamación y el dolor después de una cirugía ocular. La presentación destacará la eficacia del medicamento para proporcionar un rápido alivio de la inflamación y el dolor, con mejoras visibles tan pronto como cuatro días después de la cirugía en comparación con el placebo. También demostró una mejora más rápida en la agudeza visual y un perfil de seguridad favorable.
Eyenovia lanzó clobetasol comercialmente el 26 de septiembre de 2024. El medicamento está disponible a través de su socio farmacéutico, Medvantx, o directamente en EyenoviaRx.com. Con su conveniente dosificación de dos veces al día y un modelo de distribución simplificado, Eyenovia cree que clobetasol se convertirá rápidamente en un esteroide postoperatorio preferido por médicos y pacientes.
Eyenovia, Inc. (NASDAQ: EYEN)는 2024년 미국 안과학회(AAO) 엑스포에서 클로베타솔 프로피오네이트 현탁액 0.05%에 대한 성공적인 3상 연구(CPN-302)의 결과를 발표했습니다. 이 연구는 안과 수술 후 염증과 통증 치료를 위한 FDA 승인을 이끌어냈습니다. 발표에서는 급속한 염증과 통증 완화에 대한 약물의 효능을 강조하며, 수술 후 4일 만에 개선 효과를 나타냈습니다(플라시보 대비). 또한 시력 개선이 더 빠르게 나타나고 안전성 프로파일도 긍정적으로 평가되었습니다.
Eyenovia는 2024년 9월 26일에 클로베타솔을 상용화했습니다. 이 약물은 그들의 약국 파트너인 Medvantx를 통해 또는 EyenoviaRx.com을 통해 직접 구입할 수 있습니다. 하루 두 번 복용하는 편리함과 간소화된 유통 모델로 인해 Eyenovia는 클로베타솔이 의사와 환자들 사이에서 빠르게 선호되는 수술 후 스테로이드가 될 것이라고 믿고 있습니다.
Eyenovia, Inc. (NASDAQ: EYEN) a annoncé une présentation lors de l'Expo 2024 de l'American Academy of Ophthalmology (AAO), présentant les résultats de leur étude de Phase 3 réussie (CPN-302) sur la suspension de clobétasol propionate 0,05%. Cette étude a conduit à l'approbation de la FDA pour le traitement de l'inflammation et de la douleur après une chirurgie oculaire. La présentation mettra en avant l'efficacité du médicament à fournir un soulagement rapide de l'inflammation et de la douleur, avec des améliorations visibles dès quatre jours après la chirurgie par rapport au placebo. Elle a également démontré une amélioration plus rapide de l'acuité visuelle et un profil de sécurité favorable.
Eyenovia a lancé le clobétasol commercialement le 26 septembre 2024. Le médicament est disponible via leur partenaire pharmaceutique, Medvantx, ou directement via EyenoviaRx.com. Avec son posologique pratique deux fois par jour et un modèle de distribution rationalisé, Eyenovia pense que le clobétasol deviendra rapidement un stéroïde postopératoire préféré parmi les médecins et les patients.
Eyenovia, Inc. (NASDAQ: EYEN) hat eine Präsentation auf der American Academy of Ophthalmology (AAO) 2024 Expo angekündigt, in der die Ergebnisse ihrer erfolgreichen Phase-3-Studie (CPN-302) zur Clobetasol-Propionat-Suspension 0,05% vorgestellt werden. Diese Studie führte zur FDA-Zulassung zur Behandlung von Entzündungen und Schmerzen nach Augenoperationen. Die Präsentation wird die Wirksamkeit des Medikaments zur schnellen Linderung von Entzündungen und Schmerzen hervorheben, wobei Verbesserungen bereits vier Tage nach der Operation im Vergleich zu Placebo sichtbar sind. Sie zeigte auch eine schnellere Verbesserung der Sehschärfe und ein günstiges Sicherheitsprofil.
Eyenovia hat Clobetasol am 26. September 2024 kommerziell eingeführt. Das Medikament ist über ihren Apothekenpartner Medvantx oder direkt über EyenoviaRx.com erhältlich. Mit der praktischen Dosierung zweimal täglich und einem optimierten Vertriebsmodell ist Eyenovia überzeugt, dass Clobetasol schnell zu einem bevorzugten postoperativen Steroid unter Ärzten und Patienten wird.
- FDA approval of clobetasol propionate suspension 0.05% for post-ocular surgery inflammation and pain
- Successful Phase 3 study results demonstrating rapid relief and improved visual acuity
- Commercial launch and availability of clobetasol through multiple channels
- Convenient twice-daily dosing regimen
- Streamlined distribution model for prescribers
- None.
Insights
The presentation of Phase 3 study results for clobetasol propionate suspension 0.05% at the AAO 2024 Expo is a significant development for Eyenovia. The study's success led to FDA approval for treating post-ocular surgery inflammation and pain, which is a important milestone. Key points include:
- Efficacy demonstrated by rapid relief of inflammation and pain within four days post-surgery compared to placebo
- Improved visual acuity recovery
- Favorable safety profile
- Convenient twice-daily dosing regimen
The commercial launch on September 26, 2024, positions Eyenovia to potentially capture market share in the post-operative ophthalmic medication space. The distribution model through Medvantx and EyenoviaRx.com aims to streamline accessibility for prescribers, which could drive adoption. However, market penetration will depend on physician acceptance and patient preference over existing treatments.
While the presentation of positive Phase 3 results is encouraging, the financial impact for Eyenovia remains to be seen. Key considerations for investors include:
- Market potential: The post-operative ophthalmic medication market is competitive, but clobetasol's efficacy and convenience could drive adoption.
- Revenue timeline: With the recent launch, it's important to monitor initial sales figures and market uptake in the coming quarters.
- Cost structure: Investors should look for details on production costs and profit margins for clobetasol.
- Cash position: With a market cap of
$38,436,687 , Eyenovia's ability to fund marketing and distribution efforts is critical.
The success of clobetasol could significantly impact Eyenovia's financial health, potentially driving revenue growth and improving its market position. However, execution in commercialization and market penetration will be key factors to watch.
Presentation details efficacy and tolerability results from the successful Phase 3 program that led to FDA approval of clobetasol propionate suspension
NEW YORK, Oct. 16, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company, today announced a presentation at the American Academy of Ophthalmology (AAO) 2024 Expo, which is being held October 19-21, in Chicago.
The presentation will detail the results of a successful Phase 3 study (CPN-302) of clobetasol propionate suspension
“We are very pleased to see the results from this successful Phase 3 study of clobetasol presented at this year’s AAO Expo,” stated Michael Rowe, Chief Executive Officer of Eyenovia. “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 through EyenoviaRx.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. Rowe concluded.
| Presentation details: | |
| Title: | Clobetasol Propionate Ophthalmic Suspension |
| 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
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 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 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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