Ann: Opthea Announces Completion of Drug Substance Campaign, page-2

Here's a summary of the key points from the document:

1. Opthea Limited has completed its drug substance Process Performance Qualification (PPQ) campaign for sozinibercept, a potential treatment for wet age-related macular degeneration (wet AMD).

2. The campaign involved successfully producing three consecutive commercial-scale drug substance batches, validating Opthea's manufacturing process.

3. This achievement is a significant milestone towards a potential Biologics License Application (BLA) filing for sozinibercept in wet AMD treatment.

4. Opthea has demonstrated its ability to consistently manufacture quality drug substance at commercial scale, which will be a key component of their BLA Chemistry, Manufacturing and Controls (CMC) module.

5. The company is well-positioned to supply both their planned drug product PPQ campaign and initial launch materials.

6. A progress update on the drug product PPQ campaign is expected in early 2025.

7. Sozinibercept is currently being evaluated in two fully enrolled pivotal Phase 3 clinical trials (COAST and ShORe) for use in combination with standard anti-VEGF-A therapies.

8. The document includes forward-looking statements and cautions about potential risks and uncertainties that could affect the company's future performance and results.

9. The announcement was made on September 18, 2024, and was authorized for release by Frederic Guerard, CEO of Opthea.