Opthea Completes COAST Final Week 52 Patient Visit
Opthea (ASX/NASDAQ:OPT) has completed the final week 52 patient visit in COAST, one of two Phase 3 pivotal trials evaluating sozinibercept for wet age-related macular degeneration (wet AMD) treatment. The COAST trial investigates the superiority and safety of sozinibercept combined with aflibercept, while the ShORe trial studies its combination with ranibizumab.
Topline results are expected in early Q2 CY25 for COAST and mid-CY25 for ShORe. The primary endpoint for both trials measures the mean change in Best Corrected Visual Acuity from baseline to week 52. Patients will continue treatment for an additional year to evaluate extended safety and tolerability. The Phase 3 program aims to support a broad label for sozinibercept's use with any anti-VEGF-A therapy in wet AMD patients. The drug has received Fast Track Designation from the US FDA.
Opthea (ASX/NASDAQ:OPT) ha completato la visita finale del paziente nella settimana 52 dello studio COAST, uno dei due trial pivotal di Fase 3 che valutano sozinibercept per il trattamento della degenerazione maculare senile umida (wet AMD). Lo studio COAST indaga la superiorità e la sicurezza di sozinibercept combinato con aflibercept, mentre lo studio ShORe esamina la sua combinazione con ranibizumab.
I risultati preliminari sono previsti all'inizio del secondo trimestre del CY25 per COAST e a metà del CY25 per ShORe. L'obiettivo primario di entrambi gli studi misura la variazione media nell'Acuità Visiva Correttamente Ottimale dal basale alla settimana 52. I pazienti continueranno il trattamento per un ulteriore anno per valutare la sicurezza e la tollerabilità prolungate. Il programma di Fase 3 mira a supportare un'etichetta ampia per l'uso di sozinibercept con qualsiasi terapia anti-VEGF-A nei pazienti con wet AMD. Il farmaco ha ricevuto la Designazione di Fast Track dalla FDA degli Stati Uniti.
Opthea (ASX/NASDAQ:OPT) ha completado la visita final del paciente en la semana 52 del estudio COAST, uno de los dos ensayos pivotal de Fase 3 que evalúan sozinibercept para el tratamiento de la degeneración macular relacionada con la edad húmeda (wet AMD). El ensayo COAST investiga la superioridad y seguridad de sozinibercept combinado con aflibercept, mientras que el ensayo ShORe estudia su combinación con ranibizumab.
Se esperan resultados preliminares a principios del segundo trimestre del CY25 para COAST y a mediados del CY25 para ShORe. El objetivo primario de ambos ensayos mide el cambio medio en la Agudeza Visual Corregida desde el inicio hasta la semana 52. Los pacientes continuarán el tratamiento durante un año adicional para evaluar la seguridad y tolerabilidad extendidas. El programa de Fase 3 tiene como objetivo respaldar una etiqueta amplia para el uso de sozinibercept con cualquier terapia anti-VEGF-A en pacientes con wet AMD. El fármaco ha recibido la Designación de Fast Track de la FDA de EE. UU.
옵테아 (ASX/NASDAQ:OPT)는 습성 나이 관련 황반 변성(wet AMD) 치료를 위한 소지니버셉트를 평가하는 두 개의 3상 주요 시험 중 하나인 COAST에서 52주 환자 방문을 완료했습니다. COAST 시험은 소지니버셉트와 아플리버셉트의 조합의 우수성과 안전성을 조사하며, ShORe 시험은 소지니버셉트와 라니비주맙의 조합을 연구합니다.
COAST의 주요 결과는 CY25의 2분기 초에, ShORe는 CY25의 중반에 발표될 예정입니다. 두 시험의 주요 목표는 기준선에서 52주까지의 최상의 교정된 시력 변화의 평균을 측정하는 것입니다. 환자들은 연장된 안전성과 내약성을 평가하기 위해 추가로 1년 동안 치료를 계속할 것입니다. 3상 프로그램은 습성 AMD 환자에서 모든 항-VEGF-A 요법과 함께 소지니버셉트의 사용을 지원하는 광범위한 라벨을 목표로 하고 있습니다. 이 약물은 미국 FDA로부터 신속 승인 지정(Fast Track Designation)을 받았습니다.
Opthea (ASX/NASDAQ:OPT) a terminé la visite du patient de la semaine 52 dans l'étude COAST, l'un des deux essais pivot de Phase 3 évaluant sozinibercept pour le traitement de la dégénérescence maculaire liée à l'âge humide (wet AMD). L'essai COAST examine la supériorité et la sécurité de sozinibercept associé à aflibercept, tandis que l'essai ShORe étudie sa combinaison avec ranibizumab.
Les résultats préliminaires sont attendus au début du deuxième trimestre CY25 pour COAST et au milieu du CY25 pour ShORe. L'objectif principal des deux essais mesure le changement moyen de l'acuité visuelle corrigée depuis la ligne de base jusqu'à la semaine 52. Les patients continueront le traitement pendant une année supplémentaire pour évaluer la sécurité et la tolérabilité prolongées. Le programme de Phase 3 vise à soutenir un large étiquetage pour l'utilisation de sozinibercept avec toute thérapie anti-VEGF-A chez les patients atteints de wet AMD. Le médicament a reçu la désignation de Fast Track de la FDA américaine.
Opthea (ASX/NASDAQ:OPT) hat die letzte Patientenvisite in Woche 52 der COAST-Studie abgeschlossen, einer der beiden entscheidenden Phase-3-Studien zur Bewertung von Sozinibercept zur Behandlung der feuchten altersbedingten Makuladegeneration (wet AMD). Die COAST-Studie untersucht die Überlegenheit und Sicherheit von Sozinibercept in Kombination mit Aflibercept, während die ShORe-Studie seine Kombination mit Ranibizumab untersucht.
Die vorläufigen Ergebnisse werden für Anfang des zweiten Quartals CY25 für COAST und Mitte CY25 für ShORe erwartet. Der primäre Endpunkt beider Studien misst die durchschnittliche Veränderung der besten korrigierten Sehschärfe von der Basislinie bis zur Woche 52. Die Patienten werden die Behandlung ein weiteres Jahr fortsetzen, um die verlängerte Sicherheit und Verträglichkeit zu bewerten. Das Phase-3-Programm zielt darauf ab, eine breite Zulassung für die Verwendung von Sozinibercept in Verbindung mit jeder Anti-VEGF-A-Therapie bei Patienten mit feuchter AMD zu unterstützen. Das Medikament erhielt die Fast-Track-Designation von der US-FDA.
- Achieved significant milestone with completion of final week 52 patient visit in COAST Phase 3 trial
- FDA Fast Track Designation received for sozinibercept in wet AMD treatment
- Comprehensive Phase 3 program designed to support broad label approval
- Final trial results not available until Q2 2025
- Additional year of testing required for extended safety data
Insights
The completion of the 52-week patient visit in the COAST Phase 3 trial represents a pivotal moment for Opthea's sozinibercept development program. This milestone is particularly significant as wet AMD affects approximately 20 million people globally, with current treatments often showing diminishing efficacy over time.
The trial design reveals a sophisticated commercial strategy: By conducting parallel studies with two different combination therapies (aflibercept and ranibizumab), Opthea is positioning sozinibercept for potential approval with any anti-VEGF-A therapy. This broad-label approach could maximize market penetration and provide physicians with greater flexibility in treatment options.
The FDA's Fast Track Designation for sozinibercept is noteworthy, as it indicates both the therapy's potential to address unmet medical needs and enables accelerated development and review processes. This could expedite market entry if the trial results prove positive.
The extended two-year safety evaluation period demonstrates a thorough approach to safety assessment, which is important for chronic conditions like wet AMD where long-term treatment is necessary. This comprehensive safety data will be vital for both regulatory approval and market adoption.
With topline results expected in early Q2 2025 for COAST and mid-2025 for ShORe, these next few months are critical. Success in these trials could position Opthea to capture a significant share of the wet AMD market, which is projected to reach $18.7 billion by 2028. The company's focus on demonstrating superiority rather than just non-inferiority suggests confidence in sozinibercept's potential to improve upon current standard of care outcomes.
COAST Phase 3 trial evaluates superiority and safety of sozinibercept combined with aflibercept in wet AMD
Company confirms topline results for COAST anticipated in early 2Q CY25
MELBOURNE, Australia and PRINCETON, N.J., Feb. 18, 2025 (GLOBE NEWSWIRE) -- Opthea Limited (ASX/NASDAQ:OPT, “Opthea”, the “Company”), a clinical-stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD), today announced that it has completed the final week 52 patient visit in COAST, the first of two Phase 3 pivotal trials investigating the superiority and safety of sozinibercept in combination with aflibercept (COAST) or ranibizumab (ShORe), compared to standard of care alone for the treatment of wet AMD. The topline results from both trials are anticipated in early Q2 CY25 (COAST) and mid-CY25 (ShORe).
“The completion of the final week 52 patient visit in COAST is an important milestone in the development of sozinibercept, as we deliver on our mission of improving visual outcomes in patients with wet AMD to enable fuller and healthier lives,” commented Frederic Guerard, PharmD, Chief Executive Officer of Opthea. “I would like to thank Charles Wykoff, MD, PhD as well as all of the COAST investigators and their clinical staff for their excellent work as we plan to announce the anticipated topline data in early Q2 CY25.”
Opthea is conducting two concurrent global pivotal Phase 3 clinical trials for the treatment of wet AMD, aiming to demonstrate superiority of sozinibercept combination therapy versus standard of care alone: COAST (Combination OPT-302 with Aflibercept Study) and ShORe (Study of OPT-302 in combination with Ranibizumab). The primary endpoint for both trials is the mean change in Best Corrected Visual Acuity (BCVA) from baseline to week 52 for sozinibercept combination therapy compared to anti-VEGF-A monotherapy. Beyond week 52, patients will continue to be treated for an additional year to evaluate extended safety and tolerability up to a two-year period. Opthea’s Phase 3 program is designed to support a broad label and, if successful, enable sozinibercept to be approved for use in combination with any anti-VEGF-A therapy in wet AMD patients. Sozinibercept has received Fast Track Designation from the US FDA for the treatment of wet AMD.
About Opthea
Opthea (ASX/NASDAQ:OPT) is a biopharmaceutical company developing novel therapies to treat vision-threatening eye diseases, including wet age‐related macular degeneration (wet AMD) and diabetic macular edema (DME), which remain leading causes of vision loss worldwide.
Opthea’s lead product candidate in Phase 3 development, sozinibercept, is a first-in-class VEGF-C/D ‘trap’ inhibitor being evaluated in combination with standard-of-care anti-VEGF-A therapies to deliver superior vision to wet AMD patients. Sozinibercept has the potential to become the first therapy in 20 years to enable patients with wet AMD live fuller and healthier lives.
To learn more, visit our website at www.opthea.com and follow us on X and LinkedIn.
Inherent Risks of Investment in Biotechnology Companies
There are a number of inherent risks associated with the development of pharmaceutical products to a marketable stage. The lengthy clinical trial process is designed to assess the safety and efficacy of a drug prior to commercialization and a significant proportion of drugs fail one or both of these criteria. Other risks include uncertainty of patent protection and proprietary rights, whether patent applications and issued patents will offer adequate protection to enable product development, the obtaining of necessary drug regulatory authority approvals and difficulties caused by the rapid advancements in technology. Companies such as Opthea are dependent on the success of their research and development projects and on the ability to attract funding to support these activities. Investment in research and development projects cannot be assessed on the same fundamentals as trading and manufacturing enterprises. Therefore, investment in companies specializing in drug development must be regarded as highly speculative. Opthea strongly recommends that professional investment advice be sought prior to such investments.
Forward-Looking Statements
This announcement contains certain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. The words “expect”, “believe”, “should”, “could”, “may”, “will”, “plan” and other similar expressions are intended to identify forward-looking statements. Forward-looking statements in this announcement include statements regarding the expected timing for topline results for the COAST and ShORe clinical trials; Opthea’s Phase 3 program being designed to support a broad label, and the commercial and clinical potential of sozinibercept, including its potential use in combination with any anti-VEGF-A therapy in wet AMD patients, if approved, its potential to become the first therapy in 20 years to enable patients with wet AMD to live fuller and healthier lives and its potential to deliver superior vision to wet AMD patients. Forward-looking statements, opinions and estimates provided in this announcement are based on assumptions and contingencies which are subject to change without notice, as are statements about market and industry trends, which are based on interpretations of current conditions. Forward-looking statements are provided as a general guide only and should not be relied upon as an indication or guarantee of future performance. They involve known and unknown risks and uncertainties and other factors, many of which are beyond the control of Opthea and its directors and management and may involve significant elements of subjective judgment and assumptions as to future events that may or may not be correct. These statements may be affected by a range of variables which could cause actual results or trends to differ materially, including but not limited to future capital requirements, the development, testing, production, marketing and sale of drug treatments, regulatory risk and potential loss of regulatory approvals, ongoing clinical studies to demonstrate sozinibercept’s safety, tolerability and therapeutic efficacy, clinical research organization and labor costs, intellectual property protections, and other factors that are of a general nature which may affect the future operating and financial performance of Opthea including risk factors set forth in Opthea’s Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (the “SEC”) on August 30, 2024, and other future filings with the SEC. Actual results, performance or achievements may vary materially from any projections and forward-looking statements and the assumptions on which those statements are based. Subject to any continuing obligations under applicable law or any relevant ASX listing rules, Opthea disclaims any obligation or undertaking to provide any updates or revisions to any forward-looking statements in this announcement to reflect any change in expectations in relation to any forward-looking statements or any change in events, conditions or circumstances on which any such statement is based, except as otherwise required by applicable law.
Authorized for release to ASX by Frederic Guerard, PharmD, CEO
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Source: Opthea Limited
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