Eyenovia Announces Launch and Commercial Availability of Clobetasol Propionate Ophthalmic Suspension 0.05% for Post-Operative Inflammation and Pain Following Ocular Surgery
Eyenovia, Inc. (NASDAQ: EYEN) has announced the U.S. launch and commercial availability of clobetasol propionate ophthalmic suspension 0.05% (Clobetasol) for treating post-operative inflammation and pain following ocular surgery. As the first new ophthalmic steroid approved in over 15 years, Clobetasol offers a twice-daily dosing regimen and streamlined distribution to eliminate insurance complications.
Recent market research involving 100 ophthalmic surgeons revealed strong interest in Clobetasol. Key findings include:
- Efficacy ranked as the most important characteristic, with ~80% of patients experiencing complete pain relief within four days post-surgery
- Safety profile was highlighted, with no single adverse event affecting more than 2% of patients
- 53% of respondents cited managed care hurdles as a significant issue, which Clobetasol's fixed-price model aims to address
Eyenovia, Inc. (NASDAQ: EYEN) ha annunciato il lancio negli Stati Uniti e la disponibilità commerciale della sospensione oftalmica di clobetasolo propionato 0,05% (Clobetasol) per trattare l'infiammazione post-operatoria e il dolore dopo un intervento oculare. Essendo il primo nuovo steroide oftalmico approvato in oltre 15 anni, Clobetasol offre un regime di dosaggio due volte al giorno e una distribuzione semplificata per eliminare le complicazioni assicurative.
Recenti ricerche di mercato coinvolgendo 100 chirurghi oftalmici hanno rivelato un forte interesse per Clobetasol. I risultati chiave includono:
- Efficacia classificata come la caratteristica più importante, con circa l'80% dei pazienti che sperimenta un completo sollievo dal dolore entro quattro giorni dopo l'intervento
- Il profilo di sicurezza è stato messo in evidenza, con nessun evento avverso che ha colpito più del 2% dei pazienti
- Il 53% dei rispondenti ha citato ostacoli nella gestione sanitaria come un problema significativo, al quale il modello di prezzo fisso di Clobetasol mira a rispondere
Eyenovia, Inc. (NASDAQ: EYEN) ha anunciado el lanzamiento en EE. UU. y la disponibilidad comercial de la suspensión oftálmica de clobetasol propionato 0,05% (Clobetasol) para tratar la inflamación y el dolor postoperatorio tras la cirugía ocular. Como el primer nuevo esteroide oftálmico aprobado en más de 15 años, Clobetasol ofrece un régimen de dosificación dos veces al día y una distribución simplificada para eliminar complicaciones con el seguro.
Una reciente investigación de mercado que involucró a 100 cirujanos oftálmicos reveló un gran interés en Clobetasol. Los hallazgos clave incluyen:
- La eficacia clasificada como la característica más importante, con aproximadamente el 80% de los pacientes experimentando un alivio completo del dolor dentro de los cuatro días posteriores a la cirugía
- Se destacó el perfil de seguridad, sin que un solo evento adverso afectara a más del 2% de los pacientes
- El 53% de los encuestados citó obstáculos en la atención administrada como un problema significativo, que el modelo de precio fijo de Clobetasol busca abordar
Eyenovia, Inc. (NASDAQ: EYEN)가 미국에서 클로베타솔 프로피온산염 안과용 현탁액 0.05% (클로베타솔)의 출시 및 상업적 가용성을 발표했습니다. 15년 만에 승인된 첫 번째 새로운 안과용 스테로이드인 클로베타솔은 하루 두 번 복용하는 용법과 보험 문제를 없애기 위한 간소화된 유통을 제공합니다.
100명의 안과 의사를 대상으로 한 최근 시장 조사에서 클로베타솔에 대한 강한 관심이 드러났습니다. 주요 발견 사항은 다음과 같습니다:
- 효능은 가장 중요한 특성으로 평가되었으며, 약 80%의 환자가 수술 후 4일 이내에 통증이 완전히 사라졌습니다.
- 2% 이상의 환자에게 영향을 미치는 부작용이 없다는 점에서 안전성 프로파일이 강조되었습니다.
- 응답자의 53%가 관리 의료의 장애물을 중요한 문제로 언급했으며, 이는 클로베타솔의 고정 가격 모델이 해결하고자 하는 부분입니다.
Eyenovia, Inc. (NASDAQ: EYEN) a annoncé le lancement et la disponibilité commerciale aux États-Unis de la suspension ophtalmique de propionate de clobétasol 0,05% (Clobétasol) pour traiter l'inflammation et la douleur post-opératoires suite à une chirurgie oculaire. En tant que premier nouveau stéroïde ophtalmique approuvé depuis plus de 15 ans, Clobétasol propose un régime posologique deux fois par jour et une distribution simplifiée afin d'éliminer les complications liées à l'assurance.
Une récente étude de marché impliquant 100 chirurgiens ophtalmiques a révélé un fort intérêt pour Clobétasol. Les principales conclusions incluent :
- Une efficacité jugée comme la caractéristique la plus importante, avec environ 80% des patients ressentant un soulagement complet de la douleur dans les quatre jours suivant la chirurgie
- Le profil de sécurité a été mis en avant, aucun événement indésirable n'affectant plus de 2 % des patients
- 53 % des répondants ont cité les obstacles à la gestion des soins comme un problème significatif, que le modèle de prix fixe de Clobétasol vise à résoudre
Eyenovia, Inc. (NASDAQ: EYEN) hat die Einführung und kommerzielle Verfügbarkeit der Clobetasol-Propionat-Augentropfen 0,05% (Clobetasol) in den USA bekannt gegeben, die zur Behandlung von postoperativer Entzündung und Schmerzen nach Augenoperationen eingesetzt werden. Als das erste neue ophthalmologische Steroid, das seit über 15 Jahren genehmigt wurde, bietet Clobetasol ein zwei Mal täglich anzuwendendes Dosierungsschema und eine vereinfachte Verteilung, um Versicherungsprobleme zu beseitigen.
Eine aktuelle Marktforschung mit 100 Augenärzten ergab ein starkes Interesse an Clobetasol. Wichtige Erkenntnisse umfassen:
- Die Wirksamkeit wurde als das wichtigste Merkmal eingestuft, wobei etwa 80% der Patienten innerhalb von vier Tagen nach der Operation eine vollständige Schmerzfreiheit erlebten
- Das Sicherheitsprofil wurde hervorgehoben, da kein einzelnes unerwünschtes Ereignis mehr als 2% der Patienten betraf
- 53% der Befragten nannten verwaltete Versorgungsprobleme als ein großes Anliegen, was das Preismodell von Clobetasol mit Festpreisen ansprechen soll
- FDA approval and commercial launch of Clobetasol, the first new ophthalmic steroid in over 15 years
- Strong efficacy with ~80% of patients experiencing complete pain relief within four days post-surgery
- Favorable safety profile with no single adverse event affecting more than 2% of patients
- Fixed-price model to eliminate insurance complications and reduce managed care hurdles
- High level of interest from ophthalmic surgeons based on market research
- None.
Insights
The launch of Clobetasol propionate ophthalmic suspension 0.05% marks a significant development in post-operative ocular care. As the first new ophthalmic steroid approved in over 15 years, it addresses a long-standing need in the field. The product's twice-daily dosing and streamlined distribution model could enhance patient compliance and accessibility.
Clinical data showing
The market research indicating strong interest from ophthalmic surgeons is encouraging. However, real-world performance and long-term safety data will be important for sustained success. The fixed-price model, addressing managed care hurdles, could be a significant differentiator in a competitive market.
Eyenovia's commercial launch of Clobetasol represents a potential inflection point for the company's financial outlook. With a current market cap of
Key financial considerations include:
- Pricing strategy: The "low fixed price" model may drive volume but could impact margins. The trade-off between accessibility and profitability will be crucial.
- Market penetration: Strong interest from surgeons suggests potential for rapid adoption, which could lead to accelerated revenue growth.
- Cost structure: Streamlined distribution may reduce operational costs, potentially improving profitability.
Investors should monitor initial sales figures, prescription trends and any updates to revenue guidance. The collaboration with Formosa Pharma for potential dry eye treatment expansion adds another layer of long-term value potential, diversifying the product pipeline.
New market research shows strong interest from ophthalmic surgeons following their review of Clobetasol’s prescribing information
NEW YORK, Sept. 26, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company, today announced the U.S. launch and commercial availability of clobetasol propionate ophthalmic suspension
“The commercial launch of Clobetasol represents a significant milestone for our company, and as the first new ophthalmic steroid to be approved in more than 15 years, a meaningful advancement in the field of ocular surgery,” stated Michael Rowe, Chief Executive Officer of Eyenovia. “With its efficacy and safety profile, convenient twice-a-day dosing regimen, and streamlined distribution that is designed to eliminate complications from insurance, we believe Clobetasol will generate strong interest among eye doctors.”
Dr. Erick Co, President & CEO of Formosa Pharma, said, “This commercial U.S. launch of clobetasol has been much anticipated and we are excited to provide this formidable therapy to ocular surgery patients in the U.S. with our partner, Eyenovia. We also look forward to further collaborating with Eyenovia to develop Clobetasol as a treatment for dry eye utilizing its Optejet® platform technology.”
Eyenovia also announced the results of its recently commissioned market research indicating a strong level of interest from ophthalmic surgeons in Clobetasol based upon their review of its prescribing information.1 Key highlights from the survey include:
- Of the 100 ophthalmic surgeons surveyed, respondents ranked efficacy as the most important characteristic of a post-operative steroid. In clinical studies of Clobetasol, approximately
80% of patients had complete relief from pain as soon as four days post-surgery (versus approximately50% for patients who had vehicle) - The safety information specific to clobetasol was also of importance with clinical study results showing no single adverse event affected more than
2% of patients - Managed care hurdles were cited by
53% of respondents as the most significant issue with prescribing ophthalmic steroids. Knowing that Clobetasol will be made available to patients at a low fixed price regardless of their insurance status was seen by surgeons as a positive way to eliminate insurance complications that burden office staff - Based solely on a review of the approved label and the way it will be distributed, the majority of respondents indicated a high level of interest in prescribing Clobetasol
About Eyenovia, Inc.
Eyenovia, Inc. (NASDAQ: EYEN) is an ophthalmic technology company developing a pipeline of microdose array print therapeutics based on its Optejet® platform technology. 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, 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
1 Data on File
FAQ
What is the new product launched by Eyenovia (EYEN) for post-operative ocular care?
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What is the dosing regimen for Eyenovia's (EYEN) new Clobetasol ophthalmic suspension?
How does Eyenovia (EYEN) plan to address insurance complications with Clobetasol?
