Tag Archive for: bevacizumab

The FDA on Wednesday rejected Outlook Therapeutics’ investigational ophthalmic bevacizumab solution ONS-5010, which the company was proposing as a treatment for wet age-related macular degeneration.

The combination treatment of AstraZeneca’s Imfinzi (durvalumab) and Lynparza (olaparib) met its primary endpoint in the Phase III DUO-O trial in advanced high-grade epithelial ovarian cancer, according to an interim analysis of the study released Wednesday.

According to data from the IMbrave150 study, the drug combo is the first treatment option in over a decade to confer significant overall survival benefit over standard of care in unresectable hepatocellular carcinoma.

Outlook Therapeutics, Inc., a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced it has re-submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010, an investigational ophthalmic therapy which, if approved, will be branded as LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).