Opthea Completes Manufacturing Milestone for Wet AMD Treatment

Opthea announced the successful completion of its drug substance Process Performance Qualification (PPQ) campaign for sozinibercept, its lead candidate for treating wet age-related macular degeneration (AMD).

The PPQ campaign involved the production of three consecutive commercial-scale batches of sozinibercept, a crucial step in validating the company's manufacturing process. This milestone follows an extensive manufacturing process development program, positioning Opthea for future regulatory submissions, according to a company news release.

“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,” Fred Guerard, PharmD, Chief Executive Officer of Opthea, said in the news release. 

As Opthea continues to advance its two pivotal phase 3 trials for sozinibercept in wet AMD, the company said the completion of this commercialization milestone is a major step towards bringing the drug to market. The company expects to share progress updates on the drug product PPQ campaign in early 2025.