Opthea Achieves Key Manufacturing Milestone for Sozinibercept

Opthea Completes Drug Substance Process Performance Qualification

Opthea Limited has achieved a significant milestone in the biopharmaceutical arena with the successful completion of its drug substance Process Performance Qualification (PPQ) campaign for sozinibercept, an innovative treatment targeting wet age-related macular degeneration (wet AMD). This achievement comes as a result of producing three consecutive commercial-scale batches, marking a pivotal step in validating Opthea's manufacturing process.

Meeting the Standards for Quality

These recently produced batches are not just a formality; they are foundational to establishing a reliable manufacturing process for sozinibercept. The process development entailed numerous stringent quality assessments, ensuring that the final products meet the rigorous standards demanded by regulatory authorities before the submission of a Biologics License Application (BLA).

Commentary from Leadership

Fred Guerard, the Chief Executive Officer of Opthea, expressed enthusiasm regarding this accomplishment. "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," he stated. This sentiment is echoed by Mark O’Neill, Vice President of Technical Operations, who underlined that this milestone positions Opthea favorably not only for the upcoming drug product PPQ campaign but also for the initial launch materials.

Future Directions and Trials

Looking ahead, Opthea continues to make strides with its two fully enrolled, pivotal Phase 3 trials, COAST and ShORe. Both trials are designed to evaluate the efficacy of sozinibercept in combination with current anti-VEGF-A treatments. Opthea is expected to provide updates on its drug product PPQ campaign by early 2025, further adding to the excitement surrounding the development of sozinibercept.

About Sozinibercept

Sozinibercept is Opthea's lead candidate aimed at treating diabetic macular edema (DME) and wet AMD. The dual-action pharmacology of sozinibercept positions it as a compelling option in a crowded market. By working in tandem with existing anti-VEGF-A therapies, it aims to enhance treatment efficacy and improve vision outcomes for patients.

About Opthea Limited

Opthea Limited is a clinical-stage biopharmaceutical firm dedicated to developing breakthrough therapies for managing retinal diseases, with a focus on conditions such as wet AMD and DME. The company has made significant advancements in the understanding of these complex diseases and is at the forefront of developing solutions that could transform the treatment landscape.

The CEO, Fred Guerard, has outlined that Opthea is positioned not only to meet immediate clinical needs but also to make broader impacts on healthcare for those suffering from retinal diseases. Through innovative research and adaptive frameworks, they are steadily moving towards commercializing their advanced drug candidates.

Investor Engagement and Inquiries

Opthea places a high premium on transparency and is open to engaging with potential investors and the public. Investor inquiries can be addressed to PJ Kelleher from LifeSci Advisors, who can provide further information about the strategic direction and milestones of the company. Media inquiries can be routed to Silvana Guerci-Lena from NorthStream Global Partners.

Frequently Asked Questions

What was the significance of completing the drug substance PPQ campaign?

This milestone is crucial for validating Opthea's manufacturing processes for sozinibercept and lays the groundwork for future regulatory filings.

How will sozinibercept enhance treatment for wet AMD?

Sozinibercept works alongside standard anti-VEGF-A therapies, potentially offering improved efficacy and better vision outcomes for patients.

What are the next steps for Opthea following this milestone?

Opthea plans to advance its drug product PPQ campaign and expects to provide updates in early 2025 regarding their progress.

Who can I contact for investor inquiries?

Investor inquiries can be sent to PJ Kelleher at LifeSci Advisors for more information about Opthea's initiatives and performance.

Where can I learn more about Opthea's therapies?

For more information about Opthea and their products, the company encourages visits to their official website.

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