Opthea Limited has announced the successful completion of its process performance qualification (PPQ) campaign for sozinibercept, its novel therapy for neovascular (“wet”) age-related macular degeneration (nAMD). According to Opthea, this is a crucial step in validating the company’s drug manufacturing process; the FDA requires PPQ to ensure that drug manufacturing facilities perform as expected.

Sozinibercept is currently being evaluated in two fully enrolled pivotal Phase 3 clinical trials, COAST and ShORe, for use in combination with standard-of-care anti-VEGF-A monotherapies (aflibercept and ranibizumab, respectively) for the treatment of nAMD. The Opthea PPQ campaign involved the production of three consecutive commercial-scale batches of sozinibercept.