Posted by Michael Wonder on 14 Nov 2025
Outlook Therapeutics announces acceptance of biologics license application by FDA for ONS-5010 as a treatment for wet AMD
13 November 2025 - Outlook Therapeutics today announced that the US FDA has acknowledged receipt of the resubmission of the biologics license application for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration.
The FDA has advised that it considers the biologics license application resubmission a complete, Class 1 response to the 27 August 2025 action letter, which results in a 60 day review period from the date of resubmission.
As a result, the FDA has set a PDUFA goal date of 31 December 2025.
