Opthea Announces Completion of Drug Substance PPQ Campaign Validating Manufacturing Process of Sozinibercept

Core Insights - Opthea Limited has successfully completed its drug substance Process Performance Qualification (PPQ) campaign for sozinibercept, a significant step towards a potential biologics license application (BLA) filing for the treatment of wet age-related macular degeneration (wet AMD) [1][2] - The completion of the PPQ campaign involved the production of three consecutive commercial-scale drug substance batches, validating Opthea's manufacturing process [1][2] - The company is advancing two pivotal Phase 3 trials of sozinibercept, demonstrating its capability to consistently manufacture quality drug substance at a commercial scale, which is crucial for the BLA Chemistry, Manufacturing and Controls (CMC) module [2][4] Company Overview - Opthea is a clinical-stage biopharmaceutical company focused on developing novel therapies for retinal diseases, including wet AMD and diabetic macular edema (DME) [3] - The lead product candidate, sozinibercept, is being evaluated in two fully enrolled pivotal Phase 3 clinical trials aimed at improving efficacy and vision gains compared to standard anti-VEGF-A agents [4]