On 8 July 2024, Outlook Therapeutics announced that it received marketing authorisation from the UK’s MHRA for its ophthalmic formulation of bevacizumab (ONS-5010, Lytenava™) for the treatment of wet AMD. Bevacizumab has been used off label for ophthalmic conditions for many years and this approval marks the first authorised ophthalmic formulation of bevacizumab in the UK.
Outlook Therapeutics’ submission to the MHRA was made under the International Recognition Procedure (IRP) introduced in January 2024. This procedure allows the MHRA to accelerate the assessment of new medicines by taking into account pre-existing approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and/or the United States.
The UK approval follows marketing authorisation granted to Lytenava™ in the EU in May 2024 for the same indication.