Posted by Michael Wonder on 30 Aug 2022
Outlook Therapeutics re-submits biologics license application for ONS-5010 as a treatment for wet AMD to the US FDA
30 August 2022 - Outlook Therapeutics today announced it has re-submitted its biologics license application to the U.S. FDA for ONS-5010, an investigational ophthalmic therapy which, if approved, will be branded as Lytenava (bevacizumab-vikg) for the treatment of wet age-related macular degeneration.
The re-submission is based on the totality of data from Outlook Therapeutics’ wet age-related macular degeneration clinical program for ONS-5010, which consists of three completed registration clinical trials - NORSE ONE, NORSE TWO and NORSE THREE – as well as a Phase 1 pharmacokinetic clinical trial and the necessary pre-clinical testing.
