Opthea Advances Toward Sozinibercept Commercialization

Opthea Limited Sponsored ADR (OPT) has released an update.

Opthea Limited has announced the successful completion of its drug substance Process Performance Qualification (PPQ) campaign for sozinibercept, marking a significant step toward a potential biologics license application for treating wet age-related macular degeneration (wet AMD). The campaign verified the manufacturing process with three successful commercial-scale batches, setting the stage for the company’s continued advancement of pivotal Phase 3 trials. A progress update on the drug product PPQ campaign is anticipated in early 2025, as Opthea aims to demonstrate consistent quality drug substance production for commercialization.

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