Opthea's Completion of Drug Substance PPQ Campaign

Opthea Limited (ASX:OPT) has announced the successful completion of its drug substance Process Performance Qualification (PPQ) campaign for sozinibercept, a major milestone for potential biologics license application (BLA) filing in wet age-related macular degeneration (wet AMD). The campaign involved the production of three consecutive commercial-scale drug substance batches, demonstrating Opthea's ability to consistently manufacture quality drug substance at commercial scale.

Executive Commentary on Drug Substance PPQ Campaign

The successful completion of the drug substance PPQ campaign is an important step towards de-risking the program and a potential biologics license application (BLA) filing of sozinibercept in wet AMD. 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 (CMC) module. We believe Opthea is well positioned to supply both our planned drug product PPQ campaign, as well as our initial launch materials. We expect to share a progress update of our drug product PPQ campaign in early 2025.

Summary of Opthea's Announcement

Opthea (ASX:OPT) has successfully completed the drug substance Process Performance Qualification (PPQ) campaign for sozinibercept, marking a significant advancement towards potential biologics license application (BLA) filing in wet age-related macular degeneration (wet AMD). The completion of this campaign validates Opthea's manufacturing process and demonstrates the company's ability to consistently produce quality drug substance at commercial scale. Opthea's progress update of the drug product PPQ campaign is expected in early 2025, indicating the company's commitment to advancing its therapeutic developments. This achievement positions Opthea to supply both the planned drug product PPQ campaign and the initial launch materials, reflecting the company's readiness to meet future demands. Opthea's continued efforts in advancing its BLA preparations for FDA approval and the potential timing of the progress update of the drug product PPQ campaign underscore the company's dedication to addressing unmet needs in the treatment of retinal diseases. The company's lead product candidate, sozinibercept, being evaluated in two fully enrolled pivotal Phase 3 clinical trials, signifies Opthea's commitment to improving overall efficacy and delivering superior vision gains in the treatment of retinal diseases. Opthea's forward-looking statements emphasize the company's cautious approach, acknowledging the known and unknown risks and uncertainties inherent in the industry. The company's disclaimer regarding the forward-looking statements reflects its commitment to transparency and compliance with applicable laws and regulations.