• Organizations: Outlook Therapeutics
Outlook resubmits wet AMD BLA for bevacizumab after FDA appeal win
Pipeline

Outlook resubmits wet AMD BLA for bevacizumab after FDA appeal win

Marks fourth attempt to secure approval for the potential first on-label bevacizumab product specifically formulated for IVT retinal use in the US.
Outlook Therapeutics wins FDA appeal for wet AMD BLA
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Outlook Therapeutics wins FDA appeal for wet AMD BLA

Decision follows company’s challenge to its third rejected package of ONS-5010 / LYTENAVA (bevacizumab-vikg); fourth submission expected in June.
FDA accepts Outlook Therapeutics' request over rejected wet AMD BLA
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FDA accepts Outlook Therapeutics' request over rejected wet AMD BLA

Company challenges decision on failed third submission package of ONS-5010 / LYTENAVA (bevacizumab-vikg), with a decision expected in May.
Leadership watch: Emmecell, ABO, Outlook, and Heidelberg make changes
Business

Leadership watch: Emmecell, ABO, Outlook, and Heidelberg make changes

Leadership changes are underway in the eyecare space—and we’ve got the latest.
FDA rejects Outlook Therapeutics' third BLA submission of bevacizumab for wet AMD
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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.
Outlook Therapeutics resubmits wet AMD BLA for bevacizumab
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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.
Outlook Therapeutics receives second FDA CRL over wet AMD BLA
Pipeline

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.
FDA accepts Outlook Therapeutics' bevacizumab BLA for wet AMD
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.
Outlook Therapeutics releases 12-week data on bevacizumab formulation for AMD
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.
FDA grants SPA for Outlook Therapeutics' NORSE EIGHT AMD trial
Pipeline

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.
FDA declines approval of Outlook Therapeutics' BLA for wet AMD
Pipeline

FDA declines approval of Outlook Therapeutics' BLA for wet AMD

Agency bases response on several issues, including lack of substantial evidence and CMC issues.