Opthea Announces Completion of Drug Substance PPQ Campaign Validating Manufacturing Process of Sozinibercept
Opthea Limited - American Depositary Shares (OPT)
Company Research
Source: GlobeNewswire
Three consecutive commercial-scale batches successfully produced Major milestone for potential BLA filing of sozinibercept in wet AMD Progress update of drug product PPQ campaign expected in early 2025 MELBOURNE, Australia and PRINCETON, N.J., Sept. 18, 2024 (GLOBE NEWSWIRE) -- Opthea Limited (ASX/NASDAQ: OPT, “Opthea”, the “Company”), a clinical-stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD), today announced the completion of its drug substance Process Performance Qualification (PPQ) campaign for sozinibercept. The PPQ campaign consisted of the production of three successful consecutive commercial-scale drug substance batches required for the validation of Opthea’s manufacturing process. The batches have been produced following an extensive manufacturing process development program. “The successful completion of the drug substance PPQ campaign
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News
- Opthea Appoints Kathy Connell to Board of Directors [Yahoo! Finance]Yahoo! Finance
- Opthea Appoints Kathy Connell to Board of DirectorsGlobeNewswire
- Opthea’s Wet AMD Program Featured at Ophthalmology EventsGlobeNewswire
- Age-Related Macular Degeneration (AMD) Drugs Market Research 2024: Lucentis, Eylea, Eylea HD, Vabysmo, Syfovre, Ranibizumab, Aflibercept, Faricimab, Biologic, Biosimilar - Global Forecast to 2029 [Yahoo! Finance]Yahoo! Finance
- Opthea to Participate in November Investor ConferencesGlobeNewswire
OPT
Sec Filings
- 11/19/24 - Form 6-K
- 11/15/24 - Form 6-K
- 11/14/24 - Form SC
- OPT's page on the SEC website