• Organizations: Outlook Therapeutics
Outlook Therapeutics receives second FDA CRL over wet AMD BLA
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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.
FDA accepts Outlook Therapeutics' bevacizumab BLA for wet AMD
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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
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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
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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.
FDA declines approval of Outlook Therapeutics' BLA for wet AMD
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FDA declines approval of Outlook Therapeutics' BLA for wet AMD

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