Opthea Completes Drug Product PPQ Campaign

Core Viewpoint - Opthea Limited has successfully completed its drug product Process Performance Qualification (PPQ) campaign for sozinibercept, which supports a potential biologics license application (BLA) filing in the first half of calendar year 2026 [2][3][4]. Company Overview - Opthea is a clinical-stage biopharmaceutical company focused on developing novel therapies for retinal diseases, particularly wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME) [5]. - The lead product candidate, sozinibercept, is a first-in-class VEGF-C/D 'trap' inhibitor, currently in Phase 3 development, aimed at providing superior vision outcomes for wet AMD patients [6]. Manufacturing and Development Progress - The PPQ campaign involved the successful production of three consecutive commercial-scale drug product batches, validating Opthea's manufacturing process for sozinibercept [3]. - The completion of the drug product PPQ campaign is a significant milestone in preparation for the potential BLA filing and commercialization of sozinibercept [4]. Future Outlook - The company is working towards the Phase 3 topline data readout for the COAST trial in early Q2 CY2025 and the ShORe trial in mid-CY2025, which are critical for the future of sozinibercept [4].