Shots:
- The FDA issued a complete response letter for the ONS-5010/LYTENAVA™ BLA resubmission, declining approval for wet AMD in its current form
- The ONS-5010 BLA resubmission was based on full NORSE trial data, including the pivotal NORSE TWO and confirmatory studies like NORSE EIGHT, a study evaluating ONS-5010 vs ranibizumab in a 12-wk trial of treatment-naïve patients with a primary efficacy endpoint at 8 wks.
- Bevacizumab-vikg (bevacizumab gamma in the EU/UK) is a recombinant humanized monoclonal antibody that binds all VEGF isoforms, blocking VEGF from binding its receptors VEGFR-1 and VEGFR-2 on endothelial cells
Ref: Outlook Therapeutics | Image: Outlook Therapeutics | Press Release
Related News: Outlook Therapeutics Reports the US FDA’s BLA Acceptance of ONS-5010 to Treat Wet Age-Related Macular Degeneration (wAMD)
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