Outlook Therapeutics, Inc.
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Latest From Outlook Therapeutics, Inc.
Outlook Therapeutics has received a CRL from the US FDA over its application for an ophthalmic formulation of bevacizumab. The company says it is working with the agency to address the various issues raised.
Outlook Therapeutics received a complete response letter citing manufacturing issues and seeking more data for Lytenava (ONS-5010), its bevacizumab injection for wet age-related macular degeneration.
Paralleling the challenges of the wet AMD market it hopes to enter, the CRL for Lytenava cites manufacturing issues, which Outlook Therapeutics feels it can easily address, as well as the need for confirmatory clinical evidence, which has left the firm scrambling for a meeting with FDA.
Henlius has successfully established the safety and preliminary efficacy of its ophthalmology-indicated bevacizumab biosimilar HLX04-O in Phase I/II trials.
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