Glaukos Announces FDA Acceptance of NDA Submission for Epioxa™
Glaukos (NYSE: GKOS) announced FDA acceptance of its New Drug Application (NDA) for Epioxa™, a next-generation corneal cross-linking therapy for keratoconus treatment. The FDA set a PDUFA date of October 20, 2025, reflecting a standard 10-month review period.
Epioxa is designed as the first FDA-approved, non-invasive corneal cross-linking therapy that doesn't require corneal epithelium removal. The therapy aims to reduce procedure times, improve patient comfort, and shorten recovery time. The NDA submission includes data from two successful Phase 3 pivotal trials showing favorable efficacy, tolerability, and safety profiles.
Keratoconus, typically diagnosed in teenage years, affects approximately 90% of cases bilaterally, with up to 20% of patients requiring corneal transplant. Unlike conventional treatments that only address symptoms, Epioxa uses a proprietary drug formulation with UV-A irradiation and supplemental oxygen to strengthen corneal tissue and halt disease progression.
Glaukos (NYSE: GKOS) ha annunciato l'accettazione da parte della FDA della sua Nuova Richiesta di Farmaco (NDA) per Epioxa™, una terapia di cross-linking corneale di nuova generazione per il trattamento del cheratocono. La FDA ha fissato una data PDUFA per il 20 ottobre 2025, riflettendo un periodo di revisione standard di 10 mesi.
Epioxa è progettato come la prima terapia di cross-linking corneale non invasiva approvata dalla FDA che non richiede la rimozione dell'epitelio corneale. La terapia mira a ridurre i tempi di procedura, migliorare il comfort del paziente e accorciare il tempo di recupero. La presentazione dell'NDA include dati di due trial pivotal di Fase 3 di successo che mostrano profili di efficacia, tollerabilità e sicurezza favorevoli.
Il cheratocono, tipicamente diagnosticato nell'adolescenza, colpisce circa il 90% dei casi in modo bilaterale, con fino al 20% dei pazienti che necessitano di trapianto corneale. A differenza dei trattamenti convenzionali che affrontano solo i sintomi, Epioxa utilizza una formulazione farmacologica proprietaria con irradiazione UV-A e ossigeno supplementare per rinforzare il tessuto corneale e fermare la progressione della malattia.
Glaukos (NYSE: GKOS) anunció la aceptación por parte de la FDA de su Nueva Solicitud de Medicamento (NDA) para Epioxa™, una terapia de cross-linking corneal de nueva generación para el tratamiento del queratocono. La FDA estableció una fecha PDUFA para el 20 de octubre de 2025, lo que refleja un período de revisión estándar de 10 meses.
Epioxa está diseñado como la primera terapia de cross-linking corneal no invasiva aprobada por la FDA que no requiere la eliminación del epitelio corneal. La terapia tiene como objetivo reducir los tiempos de procedimiento, mejorar la comodidad del paciente y acortar el tiempo de recuperación. La presentación del NDA incluye datos de dos ensayos pivotal de Fase 3 exitosos que muestran perfiles de eficacia, tolerabilidad y seguridad favorables.
El queratocono, que generalmente se diagnostica en la adolescencia, afecta aproximadamente al 90% de los casos de manera bilateral, con hasta el 20% de los pacientes que requieren un trasplante de córnea. A diferencia de los tratamientos convencionales que solo abordan los síntomas, Epioxa utiliza una formulación farmacológica patentada con irradiación UV-A y oxígeno suplementario para fortalecer el tejido corneal y detener la progresión de la enfermedad.
글라우코스 (NYSE: GKOS)는 Epioxa™에 대한 새로운 약물 신청(NDA)이 FDA의 승인을 받았다고 발표했습니다. 이는 각막 혼합 교차 결합을 위한 차세대 치료법으로, 각막 원추증 치료에 사용됩니다. FDA는 2025년 10월 20일로 PDUFA 날짜를 설정했으며, 이는 표준 10개월 검토 기간을 반영합니다.
Epioxa는 각막 상피를 제거할 필요가 없는 FDA 승인 비침습적 각막 교차 결합 치료법으로 설계되었습니다. 이 치료법은 시술 시간을 줄이고, 환자의 편안함을 개선하며, 회복 시간을 단축하는 것을 목표로 합니다. NDA 제출에는 두 개의 성공적인 3상 주요 시험에서 얻은 데이터가 포함되어 있으며, 이는 유리한 효능, 내약성 및 안전성 프로필을 보여줍니다.
각막 원추증은 일반적으로 10대에 진단되며, 약 90%의 경우 양측에 영향을 미치고, 최대 20%의 환자가 각막 이식을 필요로 합니다. 전통적인 치료법이 증상만을 다루는 것과 달리, Epioxa는 UV-A 조사 및 보조 산소와 함께 고유한 약물 조합을 사용하여 각막 조직을 강화하고 질병 진행을 중단시킵니다.
Glaukos (NYSE: GKOS) a annoncé l'acceptation par la FDA de sa Demande de Nouveau Médicament (NDA) pour Epioxa™, une thérapie de cross-linking cornéen de nouvelle génération pour le traitement du kératocône. La FDA a fixé une date PDUFA au 20 octobre 2025, reflétant une période d'examen standard de 10 mois.
Epioxa est conçu comme la première thérapie de cross-linking cornéen non invasive approuvée par la FDA qui ne nécessite pas l'ablation de l'épithélium cornéen. La thérapie vise à réduire les temps de procédure, à améliorer le confort du patient et à raccourcir le temps de récupération. La soumission de la NDA comprend des données provenant de deux essais pivots de Phase 3 réussis montrant des profils d'efficacité, de tolérabilité et de sécurité favorables.
Le kératocône, généralement diagnostiqué durant l'adolescence, touche environ 90 % des cas de manière bilatérale, avec jusqu'à 20 % des patients nécessitant une greffe de cornée. Contrairement aux traitements conventionnels qui ne traitent que les symptômes, Epioxa utilise une formulation médicamenteuse propriétaire avec irradiation UV-A et oxygène supplémentaire pour renforcer le tissu cornéen et arrêter la progression de la maladie.
Glaukos (NYSE: GKOS) hat die Akzeptanz seines New Drug Application (NDA) für Epioxa™ durch die FDA bekannt gegeben, eine Therapie zur Hornhaut-Crosslinking der nächsten Generation zur Behandlung von Keratokonus. Die FDA hat ein PDUFA-Datum für den 20. Oktober 2025 festgelegt, was einen standardmäßigen Überprüfungszeitraum von 10 Monaten widerspiegelt.
Epioxa ist als die erste von der FDA genehmigte, nicht-invasive Hornhaut-Crosslinking-Therapie konzipiert, die keine Entfernung des Hornhautepithels erfordert. Die Therapie zielt darauf ab, die Verfahrenszeiten zu verkürzen, den Komfort der Patienten zu verbessern und die Erholungszeit zu verkürzen. Der NDA-Antrag enthält Daten aus zwei erfolgreichen Phase-3-Hauptstudien, die günstige Wirksamkeits-, Verträglichkeits- und Sicherheitsprofile zeigen.
Keratokonus, der typischerweise in der Jugend diagnostiziert wird, betrifft etwa 90 % der Fälle bilateral, wobei bis zu 20 % der Patienten eine Hornhauttransplantation benötigen. Im Gegensatz zu herkömmlichen Behandlungen, die nur die Symptome ansprechen, verwendet Epioxa eine proprietäre Arzneimittelzusammensetzung mit UV-A-Bestrahlung und zusätzlichem Sauerstoff, um das Hornhautgewebe zu stärken und das Fortschreiten der Krankheit zu stoppen.
- Successfully completed two Phase 3 pivotal trials meeting primary efficacy endpoints
- Potential to be first FDA-approved non-invasive treatment without epithelium removal
- Technology improvements promising shorter procedure times and recovery
- Built on established iLink platform with over 300 peer-reviewed publications
- Long regulatory timeline with PDUFA date set for October 2025
- Faces existing competition from conventional treatments
- FDA approval not guaranteed despite acceptance of NDA
Insights
The FDA's acceptance of Glaukos' Epioxa NDA marks a pivotal advancement in keratoconus treatment. The key differentiator of this next-generation therapy lies in its non-invasive approach that preserves the corneal epithelium, addressing a critical limitation of current treatments. This innovation could significantly expand the addressable market by potentially improving patient comfort, reducing procedure times, and shortening recovery periods.
The successful Phase 3 trials demonstrating both efficacy and favorable safety profiles substantially strengthen the probability of FDA approval. Particularly noteworthy is Epioxa's proprietary drug formulation featuring enhanced UV-A irradiation protocol and supplemental oxygen, which enables epithelium penetration without removal - a significant technical achievement in ophthalmology.
From a market perspective, this development is especially significant given that keratoconus affects both eyes in
The extensive validation of Glaukos' iLink platform through over 300 peer-reviewed publications provides a strong foundation for market adoption. If approved, Epioxa would be the first FDA-approved non-invasive cross-linking therapy, potentially capturing significant market share from both conventional treatments and the current Epi-off procedure.
PDUFA Date Set for October 20, 2025
“The acceptance of the Epioxa NDA represents another important step 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 throughout their 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 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, the continued efficacy and safety profile of our products when commercially marketed as compared to their pre-approval clinical trial results, and the extent to which the FDA completes its review of the Epioxa NDA by October 20, 2025, particularly in view of recent and anticipated actions by the current administration that could adversely affect staffing levels and funding for the FDA and as a result, prevent or delay marketing approvals. 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 Securities and Exchange Commission (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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, which was filed with the SEC on November 5, 2024, and our Annual Report on Form 10-K for the year ended December 31, 2024, which is expected to be filed with the SEC by March 3, 2025. 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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