- Organizations: Outlook Therapeutics
Business
Leadership watch: Emmecell, ABO, Outlook, and Heidelberg make changes
Leadership changes are underway in the eyecare space—and we’ve got the latest.
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FDA rejects Outlook Therapeutics' third BLA submission of bevacizumab for wet AMD
Agency cites need for confirmatory evidence of efficacy as reason for latest CRL; ONS-5010 is already approved in the EU and UK as LYTENAVA.
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Outlook Therapeutics resubmits wet AMD BLA for bevacizumab
Company’s third submission of ONS-5010 (bevacizumab-vikg) reportedly addresses prior issues raised in the FDA’s company response letter.
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Outlook Therapeutics receives second FDA CRL over wet AMD BLA
Agency rejects submission of bevacizumab-vikg for a second time, citing a single issue with the application: a lack of effectiveness data.Pipeline
FDA accepts Outlook Therapeutics' bevacizumab BLA for wet AMD
With a PDUFA date of Aug. 27, ONS-5010 (LYTENAVA) could become the first FDA-approved bevacizumab formulation targeting this retinal disease.Pipeline
Outlook Therapeutics releases 12-week data on bevacizumab formulation for AMD
Intravitreal injection of bevacizumab-vikg demonstrates noninferiority to ranibizumab as company plans for Q1 2025 BLA resubmission.
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FDA grants SPA for Outlook Therapeutics' NORSE EIGHT AMD trial
The 90-day non-inferiority trial on bevacizumab-vikg would support a potential BLA submission by the end of 2024.
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