Glaukos Submits New Drug Application to U.S. FDA for Epioxa™
Glaukos (NYSE: GKOS) has submitted a New Drug Application (NDA) to the FDA for Epioxa™, a next-generation corneal cross-linking therapy for keratoconus treatment. The therapy is designed to be the first FDA-approved, non-invasive treatment that preserves the corneal epithelium. The NDA submission includes successful data from two Phase 3 pivotal trials showing favorable efficacy, tolerability, and safety profiles.
Epioxa features a proprietary drug formulation designed to penetrate the epithelium, utilizing stronger UV-A irradiation and supplemental oxygen to enhance cross-linking. The therapy aims to reduce procedure times, improve patient comfort, and shorten recovery time compared to conventional treatments. Keratoconus affects approximately 90% of cases bilaterally, with up to 20% of patients requiring corneal transplants if left untreated.
Glaukos (NYSE: GKOS) ha presentato una Nuova Domanda di Farmaco (NDA) alla FDA per Epioxa™, una terapia di cross-linking corneale di nuova generazione per il trattamento del cheratocono. Questa terapia è progettata per essere il primo trattamento non invasivo approvato dalla FDA che preserva l'epitelio corneale. La presentazione della NDA include dati di successo provenienti da due studi pivotali di Fase 3 che dimostrano profili di efficacia, tollerabilità e sicurezza favorevoli.
Epioxa presenta una formulazione farmacologica proprietaria progettata per penetrare nell'epitelio, utilizzando una radiazione UV-A più intensa e ossigeno supplementare per migliorare il cross-linking. La terapia mira a ridurre i tempi di intervento, migliorare il comfort del paziente e accorciare i tempi di recupero rispetto ai trattamenti convenzionali. Il cheratocono colpisce circa il 90% dei casi bilaterali, con fino al 20% dei pazienti che necessitano di trapianti corneali se non trattati.
Glaukos (NYSE: GKOS) ha presentado una Nueva Solicitud de Medicamento (NDA) a la FDA para Epioxa™, una terapia de cross-linking corneal de nueva generación para el tratamiento del queratocono. Esta terapia está diseñada para ser el primer tratamiento no invasivo aprobado por la FDA que preserva el epitelio corneal. La presentación del NDA incluye datos exitosos de dos ensayos pivotal de Fase 3 que muestran perfiles de eficacia, tolerancia y seguridad favorables.
Epioxa cuenta con una formulación farmacéutica propietaria diseñada para penetrar en el epitelio, utilizando una irradiación UV-A más potente y oxígeno suplementario para mejorar el cross-linking. La terapia tiene como objetivo reducir el tiempo de procedimiento, mejorar la comodidad del paciente y acortar el tiempo de recuperación en comparación con los tratamientos convencionales. El queratocono afecta aproximadamente al 90% de los casos bilateralmente, y hasta el 20% de los pacientes requiere trasplantes de córnea si no se trata.
글라우코스 (NYSE: GKOS)는 Epioxa™의 FDA에 대한 신약 신청서(NDA)를 제출했습니다. Epioxa™는 각막 교차 연결 요법으로, 각막 원추증 치료를 위해 설계된 차세대 비침습적인 치료법입니다. 이 요법은 각막 상피를 보존하는 FDA 승인 첫 번째 치료법으로 설계되었습니다. NDA 제출에는 두 개의 3상 주요 시험에서 얻은 성공적인 데이터가 포함되어 있으며, 효능, 내약성 및 안전성 프로필이 긍정적으로 나타났습니다.
Epioxa는 각막 상피에 침투하도록 설계된 독점적 약물 제형을 특징으로 하며, 더 강력한 UV-A 조사 및 보조 산소를 사용하여 교차 연결을 향상시킵니다. 이 요법은 절차 시간을 줄이고, 환자 편안함을 개선하며, 기존 치료법에 비해 회복 시간을 단축하는 것을 목표로 합니다. 각막 원추증은 약 90%의 환자에서 양측성으로 발생하며, 치료하지 않을 경우 최대 20%의 환자가 각막 이식이 필요합니다.
Glaukos (NYSE: GKOS) a soumis une Demande de Nouveau Médicament (NDA) à la FDA pour Epioxa™, une thérapie de croisement cornéenne de nouvelle génération pour le traitement du kératocône. La thérapie est conçue pour être le premier traitement non invasif approuvé par la FDA qui préserve l'épithélium cornéen. La soumission du NDA inclut des données réussies provenant de deux essais pivots de Phase 3 montrant des profils d'efficacité, de tolérabilité et de sécurité favorables.
Epioxa se distingue par une formulation médicamenteuse propriétaire conçue pour pénétrer l'épithélium, utilisant une irradiation UV-A plus puissante et de l'oxygène supplémentaire pour améliorer le croisement. La thérapie vise à réduire les temps d'intervention, à améliorer le confort du patient et à raccourcir le temps de récupération par rapport aux traitements conventionnels. Le kératocône touche environ 90 % des cas bilatéraux, avec jusqu'à 20 % des patients nécessitant des greffes de cornée si laissé sans traitement.
Glaukos (NYSE: GKOS) hat einen neuen Arzneimittelantrag (NDA) bei der FDA für Epioxa™ eingereicht, eine neuartige Therapie zur kornealen Quervernetzung zur Behandlung von Keratokonus. Die Therapie ist darauf ausgelegt, die erste von der FDA zugelassene, nicht-invasive Behandlung zu sein, die das Hornhautepithel erhält. Die NDA-Einreichung umfasst erfolgreiche Daten aus zwei zulassungsrelevanten Phase-3-Studien, die günstige Wirksamkeit, Verträglichkeit und Sicherheitsprofile zeigen.
Epioxa verfügt über eine proprietäre Arzneimittel-Formulierung, die darauf ausgelegt ist, das Epithel zu durchdringen, wobei stärkere UV-A-Bestrahlung und zusätzliches Sauerstoff zur Verbesserung der Quervernetzung verwendet werden. Die Therapie zielt darauf ab, die Verfahrenszeiten zu verkürzen, den Komfort des Patienten zu verbessern und die Erholungszeit im Vergleich zu herkömmlichen Behandlungen zu verkürzen. Keratokonus betrifft etwa 90 % der Fälle bilateral, wobei bis zu 20 % der Patienten eine Hornhauttransplantation benötigen, wenn sie unbehandelt bleiben.
- Successful completion of two Phase 3 pivotal trials meeting primary efficacy endpoints
- Potential first-mover advantage in non-invasive corneal cross-linking therapy
- Technology addresses limitations of current treatments with shorter procedure times and recovery
- FDA approval still pending and uncertain
- Will compete with company's existing Photrexa® treatment
Insights
The NDA submission for Epioxa represents a potentially transformative development in keratoconus treatment. The key innovation lies in its non-invasive approach that preserves the corneal epithelium, addressing significant limitations of current FDA-approved treatments. The successful Phase 3 trials meeting primary efficacy endpoints, coupled with favorable safety profiles, substantially strengthen the application's prospects.
The market opportunity is compelling - keratoconus affects roughly 1 in 2,000 people, with 90% bilateral cases and up to 20% requiring corneal transplants. Epioxa's potential to reduce procedure times and recovery periods while improving patient comfort could drive significant market adoption. The extensive validation through 300+ peer-reviewed publications supporting iLink therapy provides robust credibility.
For investors, approval would give Glaukos a significant competitive advantage in the
This NDA submission marks a critical catalyst for Glaukos's market position and potential revenue growth. The innovative Epioxa technology addresses a clear unmet medical need while building upon the company's established first-generation iLink platform. If approved, Epioxa could significantly expand the addressable market by attracting patients who previously hesitated due to the invasive nature of current treatments.
The market implications are substantial given that keratoconus typically affects younger patients requiring long-term treatment. The improved patient experience and potentially better compliance could drive faster market penetration and higher procedure volumes. The proprietary drug formulation and delivery method also create barriers to competition, potentially supporting premium pricing and higher margins.
With a market cap of
“The NDA submission for Epioxa represents an important milestone for our company as it brings us one step closer in being able to provide keratoconus patients and the ophthalmic community with the first FDA-approved, non-invasive corneal cross-linking drug therapy that does not require removal of the corneal epithelium, the outermost layer of the front of the eye,” said Thomas Burns, Glaukos chairman and chief executive officer. “We look forward to working closely with the FDA in their pending review process and continue to believe Epioxa, which is designed to reduce procedure times, improve patient comfort and shorten recovery time, represents a potentially meaningful advancement in the treatment paradigm for patients suffering from keratoconus.”
The NDA submission includes data from two Phase 3 pivotal trials of Epioxa, which both successfully achieved the pre-specified primary efficacy endpoints and demonstrated favorable tolerability and safety profiles.
Glaukos’ corneal cross-linking iLink therapies use proprietary, bio-activated drug formulations designed to strengthen corneal tissue and halt progression of keratoconus. Typically diagnosed in a patient’s teenage years, keratoconus is a debilitating eye condition characterized by progressive thinning and weakening of the cornea. If left untreated, keratoconus can lead to loss of vision and even blindness and is one of the leading causes of corneal transplant (penetrating keratoplasty) in
Epioxa, which is designed to preserve the corneal epithelium, reduce procedure times, improve patient comfort and shorten recovery time, utilizes a proprietary, novel drug formulation designed to penetrate the epithelial layer of the cornea, a stronger UV-A irradiation protocol and supplemental oxygen to enhance cross-linking. If approved, the company anticipates Epioxa would be the first FDA-approved, non-invasive corneal cross-linking therapy that does not require removal of the corneal epithelium, the outermost layer of the front of the eye.
About Glaukos
Glaukos (www.glaukos.com) is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. Glaukos first developed Micro-Invasive Glaucoma Surgery (MIGS) as an alternative to the traditional glaucoma treatment paradigm, launching its first MIGS device commercially in 2012. In 2024, Glaukos commenced commercial launch activities for iDose® TR, a first-of-its-kind, long-duration, intracameral procedural pharmaceutical designed to deliver 24/7 glaucoma drug therapy inside the eye for extended periods of time. Glaukos also markets the only FDA-approved corneal cross-linking therapy utilizing a proprietary bio-activated pharmaceutical for the treatment of keratoconus, a rare corneal disorder. Glaukos continues to successfully develop and advance a robust pipeline of novel, dropless platform technologies designed to meaningfully advance the standard of care and improve outcomes for patients suffering from chronic eye diseases.
Forward-Looking Statements
All statements other than statements of historical facts included in this press release that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for forward-looking statements contained herein, we caution you that they are based on current expectations about future events affecting us and are subject to risks, uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control, that may cause our actual results to differ materially from those expressed or implied by forward-looking statements in this press release. These potential risks and uncertainties include, without limitation, the extent to which we may obtain regulatory approval for Epioxa or other investigational products, our ability to successfully commercialize such products, and the continued efficacy and safety profile of our products when commercially marketed as compared to their pre-approval clinical trial results. Historical, current and forward-looking sustainability-related statements may be based on standards for measuring progress that are still developing, internal controls and process that continue to evolve, and assumptions that are subject to change in the future. The information included in, and any issues identified as material for purposes of this document may not be considered material for SEC reporting purposes. In the context of this disclosure, the term “material” is distinct from, and should not be confused with, such term as defined for SEC reporting purposes. These and other risks, uncertainties and factors related to Glaukos, and our business are described in detail under the caption “Risk Factors” and elsewhere in our Annual Report on Form 10-Q for the quarter ended September 30, 2024, which was filed with the Securities and Exchange Commission (SEC) on November 5, 2024. Our filings with the SEC are available in the Investor Section of our website at www.glaukos.com or at www.sec.gov. In addition, information about the risks and benefits of our products is available on our website at www.glaukos.com. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof. We do not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.
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Media Contact:
Michele Gray
(917) 449-9250
michele@mgraycommunications.com
Investor Contact:
Chris Lewis
Vice President, Investor Relations & Corporate Affairs
(949) 481-0510
clewis@glaukos.com
Source: Glaukos Corporation
FAQ
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