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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