Outlook’s Ophthalmic Bevacizumab Knocked Back By FDA
US Agency Offers Multiple Reasons For CRL Over Outlook’s BLA For Lytenava
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.
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Pinning its hopes on its proposed bevacizumab product for ophthalmic indications, Outlook Therapeutics has been told to give more information to the US FDA ahead of an approval. However, one analyst remained upbeat for the company’s prospects.
The American Academy of Ophthalmology has criticized healthcare insurers for pushing bevacizumab biosimilar alternatives to Avastin, like Pfizer’s Zirabev and Amgen’s Mvasi, that have not been subjected to clinical trials in eye disease or testing for retinal toxicity.
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