Posted by Michael Wonder on 23 Dec 2022
Outlook Therapeutics announces validation of marketing authorisation application by the European Medicines Agency for ONS-5010 as a treatment for wet AMD
22 December 2022 - Submission follows the US FDA acceptance of the ONS-5010 BLA for wet AMD, with a PDUFA date of 29 August 2023.
Outlook Therapeutics today announced the validation of its marketing authorisation application by the EMA for ONS-5010/Lytenava (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration.
