Glaukos Announces Positive Clinical Updates for its iDose® Sustained-Release Procedural Pharmaceutical Platform
Glaukos (NYSE: GKOS) announced positive clinical updates for its iDose® sustained-release procedural pharmaceutical platform. In a 36-month follow-up analysis of Phase 3 trials, iDose TR demonstrated sustained IOP reductions with approximately 70% of subjects remaining well-controlled, compared to 58% of timolol control subjects.
The company has initiated a Phase 2b/3 clinical program for iDose TREX, its next-generation therapy with nearly twice the drug capacity. A 6-month Phase 4 study showed iDose TR combined with cataract surgery achieved a mean IOP reduction of 11.3 mmHg (44%) in open-angle glaucoma patients.
The iDose platform is designed to address patient non-adherence and side effects associated with topical medications by providing 24/7, long-duration efficacy with minimal side effects.
Glaukos (NYSE: GKOS) ha annunciato aggiornamenti clinici positivi per la sua piattaforma farmacologica iDose® a rilascio sostenuto. In un'analisi di follow-up di 36 mesi degli studi di Fase 3, iDose TR ha dimostrato riduzioni sostenute della pressione intraoculare (IOP) con circa il 70% dei soggetti che rimanevano ben controllati, rispetto al 58% dei soggetti di controllo trattati con timololo.
L'azienda ha avviato un programma clinico di Fase 2b/3 per iDose TREX, la sua terapia di nuova generazione che ha quasi il doppio della capacità del farmaco. Uno studio di Fase 4 di 6 mesi ha mostrato che iDose TR, combinato con la chirurgia della cataratta, ha ottenuto una riduzione media della IOP di 11,3 mmHg (44%) nei pazienti con glaucoma ad angolo aperto.
La piattaforma iDose è progettata per affrontare la non aderenza dei pazienti e gli effetti collaterali associati ai farmaci topici, fornendo un'efficacia a lungo termine 24 ore su 24, con effetti collaterali minimi.
Glaukos (NYSE: GKOS) anunció actualizaciones clínicas positivas para su plataforma farmacéutica de liberación sostenida iDose®. En un análisis de seguimiento de 36 meses de los ensayos de Fase 3, iDose TR demostró reducciones sostenidas en la presión intraocular (PIO) con aproximadamente el 70% de los sujetos manteniéndose bien controlados, en comparación con el 58% de los sujetos de control con timolol.
La compañía ha iniciado un programa clínico de Fase 2b/3 para iDose TREX, su terapia de próxima generación que tiene casi el doble de capacidad de fármaco. Un estudio de Fase 4 de 6 meses mostró que iDose TR combinado con cirugía de cataratas logró una reducción media de la PIO de 11,3 mmHg (44%) en pacientes con glaucoma de ángulo abierto.
La plataforma iDose está diseñada para abordar la falta de adherencia de los pacientes y los efectos secundarios asociados con los medicamentos tópicos, proporcionando eficacia a largo plazo las 24 horas del día, con efectos secundarios mínimos.
글라우코스 (NYSE: GKOS)는 자사의 지속 방출 제약 플랫폼인 iDose®에 대한 긍정적인 임상 업데이트를 발표했습니다. 3상 시험의 36개월 추적 분석에서 iDose TR은 안압(IOP)의 지속적인 감소를 보여주었으며, 약 70%의 피험자가 잘 조절된 상태를 유지한 반면, timolol 대조군 피험자의 경우 58%였습니다.
회사는 약물이 거의 두 배의 용량을 가진 차세대 치료제인 iDose TREX에 대한 2b/3상 임상 프로그램을 시작했습니다. 6개월 간의 4상 연구에서는 iDose TR이 백내장 수술과 함께 시행되었을 때 개방각녹내장 환자에서 평균 11.3 mmHg (44%)의 안압 감소를 달성했습니다.
iDose 플랫폼은 24시간 지속적인 효능을 제공하며 부작용을 최소화하여 환자의 비순응 및 국소 약물과 관련된 부작용 문제를 해결하도록 설계되었습니다.
Glaukos (NYSE: GKOS) a annoncé des mises à jour cliniques positives pour sa plateforme pharmaceutique à libération durable iDose®. Dans une analyse de suivi de 36 mois des essais de Phase 3, iDose TR a démontré des réductions continues de la pression intraoculaire (PIO) avec environ 70 % des sujets restant bien contrôlés, comparativement à 58 % des sujets contrôlés par timolol.
L'entreprise a lancé un programme clinique de Phase 2b/3 pour iDose TREX, sa thérapie de nouvelle génération ayant presque le double de la capacité médicamenteuse. Une étude de Phase 4 de 6 mois a montré que iDose TR, associé à une chirurgie de la cataracte, a obtenu une réduction moyenne de la PIO de 11,3 mmHg (44 %) chez les patients atteints de glaucome à angle ouvert.
La plateforme iDose est conçue pour résoudre le problème de non-adhérence des patients et des effets secondaires associés aux médicaments topiques en offrant une efficacité à long terme 24 heures sur 24, avec des effets secondaires minimaux.
Glaukos (NYSE: GKOS) hat positive klinische Updates für seine iDose® Plattform für die sostenierte Arzneimittelfreisetzung angekündigt. In einer 36-monatigen Nachbeobachtungsanalyse der Phase-3-Studien zeigte iDose TR nachhaltige Senkungen des Augeninnendrucks (IOP), wobei etwa 70 % der Probanden gut kontrolliert blieben, verglichen mit 58 % der mit Timolol behandelten Kontrollgruppe.
Das Unternehmen hat ein klinisches Programm der Phase 2b/3 für iDose TREX initiiert, eine Therapie der nächsten Generation mit nahezu doppelter Arzneimittelkapazität. Eine 6-monatige Phase-4-Studie zeigte, dass iDose TR in Kombination mit einer Kataraktoperation eine durchschnittliche IOP-Senkung von 11,3 mmHg (44 %) bei Patienten mit Offenwinkelglaukom erzielte.
Die iDose-Plattform ist darauf ausgelegt, die Patientenbindung zu verbessern und Nebenwirkungen von topischen Medikamenten zu reduzieren, indem eine langanhaltende Wirksamkeit rund um die Uhr mit minimalen Nebenwirkungen bereitgestellt wird.
- iDose TR showed 70% patient control rate at 36 months vs 58% for timolol control
- Phase 4 study demonstrated 44% IOP reduction (11.3 mmHg) at 6 months
- Next-generation iDose TREX features double drug capacity
- Excellent tolerability and favorable safety profile through 36 months
- None.
Insights
The 36-month follow-up analysis of iDose TR's Phase 3 trials reveals remarkable efficacy and durability. The
The initiation of the Phase 2b/3 program for iDose TREX represents a significant advancement. With double the drug capacity of the original iDose TR, this next-generation platform could potentially extend treatment duration beyond the current 36-month window, addressing one of the key limitations in glaucoma management. The maintained safety profile through 36 months substantially de-risks the platform's long-term clinical adoption.
The clinical updates substantially strengthen Glaukos's market position in the
The combination therapy data with cataract surgery is particularly valuable, as it opens up an additional revenue stream in the large cataract surgery market. With approximately 4 million cataract surgeries performed annually in the US alone, this represents a substantial market opportunity. The platform's ability to address medication non-adherence - a major challenge costing the healthcare system billions annually - strengthens its value proposition to payers and providers.
-
In a new 36-month follow-up analysis of its two Phase 3 pivotal clinical trials, iDose TR (travoprost intracameral implant) 75 mcg, an FDA-approved prostaglandin analog indicated for the reduction of intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma, demonstrated sustained substantial IOP reductions as approximately
70% of iDose TR subjects remained well-controlled on the same or fewer IOP-lowering topical medications at 36 months after a single administration of iDose TR, versus58% of timolol control subjects. In addition, iDose TR continued to demonstrate excellent tolerability and a favorable safety profile through 36 months across both Phase 3 trials.
- Glaukos has commenced a Phase 2b/3 clinical program for iDose TREX, its next-generation iDose sustained-release procedural pharmaceutical platform therapy. iDose TREX is designed to be very similar in size and form factor to the original iDose TR but has nearly twice the drug capacity.
-
In a new 6-month follow-up analysis of a Phase 4 single-arm clinical study that evaluated 60 open-angle glaucoma patients, iDose TR implanted in combination with cataract surgery achieved a mean IOP reduction of 11.3 mmHg, or
44% , at 6 months compared to baseline.
“We are pleased to share these positive clinical updates on our iDose procedural pharmaceutical platform, helping to further advance our goal to position iDose as a transformative novel platform technology able to fundamentally improve the treatment paradigm for patients with glaucoma or ocular hypertension,” said Thomas Burns, Glaukos chairman and chief executive officer. “We continue to believe there is an important unmet clinical need and strong appetite within the ophthalmic community for safe, effective and sustained procedural pharmaceutical alternatives to traditional topical medications. These clinical updates leave us ideally positioned to advance our mission to transform vision therapies for the benefit of patients around the globe suffering from chronic eye diseases.”
Glaukos’ iDose sustained-release procedural pharmaceutical platform consists of a targeted, minimally-invasive, injectable implant designed to deliver therapeutic levels of medication from within the eye for extended periods of time. The iDose platform is designed to address ubiquitous patient non-adherence and chronic side effects associated with topical medications by providing 24/7, long-duration, robust efficacy with minimal side effects. Given Glaukos’ development success to date with iDose TR, the company continues to invest resources to expand its pharmaceutical development capabilities and develop future iDose solutions.
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 implant 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.
About iDose® TR (
iDose TR (travoprost intracameral implant) is a long duration prostaglandin analog approved for a single administration and indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Made from medical-grade titanium, iDose TR is implanted through the trabecular meshwork and back wall of Schlemm's canal, directly into scleral tissue. Once implanted, 75 mcg of a novel, preservative-free, proprietary formulation of travoprost continuously elutes into the anterior chamber via membrane-controlled diffusion, allowing for 24/7 release of medication.
Indication for Use: iDose TR (travoprost intracameral implant) is indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT).
Dosage and Administration: For ophthalmic intracameral administration. The intracameral administration should be carried out under standard aseptic conditions.
Contraindications: iDose TR is contraindicated in patients with active or suspected ocular or periocular infections, patients with corneal endothelial cell dystrophy (e.g., Fuch’s Dystrophy, corneal guttatae), patients with prior corneal transplantation, or endothelial cell transplants (e.g., Descemet’s Stripping Automated Endothelial Keratoplasty [DSAEK]), patients with hypersensitivity to travoprost or to any other components of the product.
Warnings and Precautions: iDose TR should be used with caution in patients with narrow angles or other angle abnormalities. Monitor patients routinely to confirm the location of the iDose TR at the site of administration. Increased pigmentation of the iris can occur. Iris pigmentation is likely to be permanent.
Adverse Reactions: In controlled studies, the most common ocular adverse reactions reported in
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 iDose platform therapies 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250114301306/en/
Media Contact:
Andria Arena
aarena@jpa.com
Investor Contact:
Chris Lewis
Vice President, Investor Relations & Corporate Affairs
(949) 481-0510
clewis@glaukos.com
Source: Glaukos Corporation
FAQ
What were the 36-month results for Glaukos (GKOS) iDose TR Phase 3 trials?
How effective was GKOS iDose TR when combined with cataract surgery?
What are the key differences between Glaukos iDose TREX and original iDose TR?
What advantages does GKOS iDose platform offer over traditional glaucoma treatments?
