Opthea completes drug substance PPQ campaign for sozinibercept

Opthea announced the completion of its drug substance Process Performance Qualification campaign for sozinibercept. The PPQ campaign consisted of the production of three successful consecutive commercial-scale drug substance batches required for the validation of Opthea’s manufacturing process. The batches have been produced following an extensive manufacturing process development program. “The successful completion of the drug substance PPQ campaign is an important step towards de-risking the program and a potential biologics license application filing of sozinibercept in wet AMD,” commented Fred Guerard, PharmD, CEO. “While we continue to advance our two fully enrolled, pivotal Phase 3 trials of sozinibercept in wet AMD, we now have demonstrated our ability to consistently manufacture quality drug substance at commercial scale, which will serve as a key component of our BLA Chemistry, Manufacturing and Controls module.”