Opthea Limited announced the completion of its drug product Process Performance Qualification (PPQ) campaign for sozinibercept.

The PPQ campaign consisted of the successful production of 3 consecutive commercial-scale drug product batches required to further validate Opthea’s manufacturing process in preparation for a potential biologics license application (BLA) filing and commercialization of sozinibercept in wet AMD, the company said in a press release. The batches have been produced subsequent to the successful completion of the drug substance PPQ campaign announced in September 2024.

“The successful completion of the drug product PPQ campaign is a critical step in support of a potential BLA filing of sozinibercept in wet AMD in the first half of CY2026,” said Fred Guerard, PharmD, chief executive officer of Opthea, in the press release. “As we continue to work towards the phase 3 topline data readout of COAST in early Q2 CY2025 and ShORe in mid-CY2025, we now have demonstrated our ability to consistently manufacture quality drug product at commercial scale to support a potential approval and launch of sozinibercept in wet AMD.”