Posted by Michael Wonder on 01 Mar 2025
Outlook Therapeutics resubmits biologics license application for ONS-5010 as a treatment for wet AMD to the US FDA
28 February 2025 - Outlook Therapeutics today announced it has re-submitted its biologics license application to the US FDA for ONS-5010, an investigational ophthalmic product which, if approved, will be branded as Lytenava (bevacizumab-vikg) for the treatment of wet age-related macular degeneration.
The ONS-5010 resubmission is based on the efficacy and safety demonstrated in NORSE EIGHT, as well as additional chemistry, manufacturing and controls information requested by the FDA.
