Opthea Completes Drug Product PPQ Campaign
Opthea (OPT) has successfully completed its drug product Process Performance Qualification (PPQ) campaign for sozinibercept, achieving production of three consecutive commercial-scale drug product batches. This milestone follows the drug substance PPQ campaign completion announced in September 2024 and supports the company's potential biologics license application (BLA) filing in the first half of 2026.
The company is developing sozinibercept for treating wet age-related macular degeneration (wet AMD). Phase 3 clinical trials are ongoing with topline data expected from the COAST study in early Q2 2025 and the ShORe study in mid-2025. This manufacturing achievement demonstrates Opthea's capability to produce quality drug product at commercial scale, positioning the company for potential approval and launch of sozinibercept in wet AMD.
Opthea (OPT) ha completato con successo la campagna di Qualificazione delle Prestazioni di Processo (PPQ) per il sozinibercept, raggiungendo la produzione di tre lotti consecutivi di prodotto farmaceutico su scala commerciale. Questo traguardo segue il completamento della campagna PPQ per la sostanza farmaceutica annunciato a settembre 2024 e supporta la potenziale presentazione della domanda di licenza per biologici (BLA) da parte dell'azienda nella prima metà del 2026.
L'azienda sta sviluppando il sozinibercept per il trattamento della degenerazione maculare legata all'età umida (wet AMD). Gli studi clinici di fase 3 sono in corso, con dati preliminari attesi dallo studio COAST all'inizio del secondo trimestre del 2025 e dallo studio ShORe a metà del 2025. Questo risultato nella produzione dimostra la capacità di Opthea di produrre un prodotto farmaceutico di qualità su scala commerciale, posizionando l'azienda per una potenziale approvazione e lancio del sozinibercept per la wet AMD.
Opthea (OPT) ha completado con éxito su campaña de Calificación de Rendimiento del Proceso (PPQ) para el sozinibercept, logrando la producción de tres lotes consecutivos de producto farmacéutico a escala comercial. Este hito sigue a la finalización de la campaña de PPQ para la sustancia activa anunciada en septiembre de 2024 y apoya la posible presentación de la solicitud de licencia de biológicos (BLA) por parte de la empresa en la primera mitad de 2026.
La empresa está desarrollando el sozinibercept para el tratamiento de la degeneración macular relacionada con la edad húmeda (wet AMD). Los ensayos clínicos de fase 3 están en curso, con datos preliminares esperados del estudio COAST a principios del segundo trimestre de 2025 y del estudio ShORe a mediados de 2025. Este logro en la fabricación demuestra la capacidad de Opthea para producir un producto farmacéutico de calidad a escala comercial, posicionando a la empresa para una posible aprobación y lanzamiento del sozinibercept en la wet AMD.
옵시아 (OPT)는 소지니베르셉트의 공정 성능 자격(PPQ) 캠페인을 성공적으로 완료하고, 상업 규모의 약물 제품 배치 3개를 연속으로 생산하는 데 성공했습니다. 이 이정표는 2024년 9월에 발표된 약물 물질 PPQ 캠페인 완료 이후에 이루어졌으며, 2026년 상반기 생물학적 제제 허가 신청(BLA) 제출 가능성을 지원합니다.
회사는 습성 노인성 황반변성(wet AMD) 치료를 위해 소지니베르셉트를 개발하고 있습니다. 3상 임상 시험이 진행 중이며, 2025년 2분기 초에 COAST 연구의 주요 데이터가 예상되고, 2025년 중반에는 ShORe 연구의 데이터가 예상됩니다. 이번 제조 성과는 옵시아가 상업 규모에서 품질 있는 약물 제품을 생산할 수 있는 능력을 보여주며, 습성 AMD에 대한 소지니베르셉트의 승인 및 출시 가능성을 높이고 있습니다.
Opthea (OPT) a réussi à compléter sa campagne de Qualification de Performance du Processus (PPQ) pour le sozinibercept, atteignant la production de trois lots consécutifs de produit pharmaceutique à l'échelle commerciale. Cet objectif fait suite à l'achèvement de la campagne PPQ pour la substance active annoncé en septembre 2024 et soutient la potentielle demande de licence biologique (BLA) de l'entreprise prévue pour le premier semestre 2026.
L'entreprise développe le sozinibercept pour traiter la dégénérescence maculaire liée à l'âge humide (wet AMD). Des essais cliniques de phase 3 sont en cours, avec des données préliminaires attendues de l'étude COAST au début du deuxième trimestre 2025 et de l'étude ShORe à la mi-2025. Ce succès en matière de fabrication démontre la capacité d'Opthea à produire un produit pharmaceutique de qualité à l'échelle commerciale, positionnant l'entreprise pour une approbation et un lancement potentiels du sozinibercept dans le cadre de la wet AMD.
Opthea (OPT) hat erfolgreich seine Kampagne zur Prozessleistungsqualifizierung (PPQ) für Sozinibercept abgeschlossen und dabei die Produktion von drei aufeinanderfolgenden Chargen von Arzneimitteln im kommerziellen Maßstab erreicht. Dieser Meilenstein folgt auf den Abschluss der PPQ-Kampagne für den Wirkstoff, die im September 2024 angekündigt wurde, und unterstützt die potenzielle Einreichung eines Biologics License Application (BLA) durch das Unternehmen in der ersten Hälfte des Jahres 2026.
Das Unternehmen entwickelt Sozinibercept zur Behandlung der feuchten altersbedingten Makuladegeneration (wet AMD). Die klinischen Studien der Phase 3 laufen, wobei die wichtigsten Daten aus der COAST-Studie Anfang des zweiten Quartals 2025 und aus der ShORe-Studie Mitte 2025 erwartet werden. Dieser Fertigungserfolg zeigt die Fähigkeit von Opthea, qualitativ hochwertige Arzneimittelprodukte im kommerziellen Maßstab herzustellen, und positioniert das Unternehmen für eine potenzielle Genehmigung und Markteinführung von Sozinibercept bei feuchter AMD.
- Successful completion of commercial-scale drug product manufacturing validation
- On track for BLA filing in 1H 2026
- Phase 3 trial results expected in Q2-mid 2025
- None.
Insights
Opthea has achieved a critical manufacturing milestone for sozinibercept, its novel therapy for wet age-related macular degeneration (wet AMD). The successful completion of the drug product Process Performance Qualification (PPQ) campaign - producing three consecutive commercial-scale batches - demonstrates the company's ability to consistently manufacture quality product at the scale needed for commercialization.
This manufacturing validation, following the earlier drug substance PPQ completion in September 2024, removes a significant operational hurdle in Opthea's regulatory pathway. The achievement is strategically timed ahead of upcoming Phase 3 data readouts from the COAST study (early Q2 2025) and ShORe study (mid-2025), positioning the company to potentially file a Biologics License Application (BLA) in the first half of 2026 if clinical results prove positive.
The proactive manufacturing preparation suggests management confidence in sozinibercept's clinical prospects. For investors, this development reduces execution risk in the company's commercialization strategy and could accelerate time-to-market if approved. Wet AMD represents a substantial market opportunity, affecting approximately 20 million people worldwide and currently dominated by anti-VEGF therapies like Eylea and Lucentis.
While this manufacturing milestone is significant, the ultimate value driver remains the pending Phase 3 clinical data. Successful manufacturing validation ensures Opthea won't face delays in bringing sozinibercept to market should clinical trials demonstrate efficacy and safety, potentially accelerating the path to revenue generation in this multi-billion dollar therapeutic area.
Three consecutive commercial-scale drug product batches successfully produced
Supports potential sozinibercept BLA filing in 1H CY2026
MELBOURNE, Australia and PRINCETON, N.J., Feb. 26, 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 the completion of its drug product Process Performance Qualification (PPQ) campaign for sozinibercept.
The PPQ campaign consisted of the successful production of three consecutive commercial-scale drug product batches required to further validate Opthea’s manufacturing process in preparation for a potential biologics license application (BLA) filing and commercialization of sozinibercept in wet AMD. The batches have been produced subsequent to the successful completion of the drug substance PPQ campaign announced in September 2024.
“The successful completion of the drug product PPQ campaign is a critical step in support of a potential BLA filing of sozinibercept in wet AMD in the first half of CY2026,” commented Fred Guerard, PharmD, Chief Executive Officer of Opthea. “As we continue to work towards the Phase 3 topline data readout of COAST in early Q2 CY2025 and ShORe in mid-CY2025, we now have demonstrated our ability to consistently manufacture quality drug product at commercial scale to support a potential approval and launch of sozinibercept in 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 to 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 potential BLA filing and approval and launch of sozinibercept in wet AMD; Opthea’s ability to produce consistent quality batches of drug product at commercial scale going into potential approval and commercialization; expected timing for topline results for the COAST and ShORe clinical trials; 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
FAQ
When will Opthea (OPT) release Phase 3 trial results for sozinibercept in wet AMD?
What is the significance of Opthea's PPQ campaign completion for sozinibercept?
When does Opthea (OPT) plan to file the BLA for sozinibercept?
What medical condition is Opthea's sozinibercept targeting?
