Outlook Pulls Bevacizumab BLA As Filing Falls Short
Plans To Submit Revised US Application With FDA In Q3
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.
You may also be interested in...
Outlook Therapeutics has confirmed that it has requested a Type A meeting with the FDA, to discuss issues raised in a complete response letter received in connection to the firm’s application for an ophthalmic formulation of bevacizumab.
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.
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.