On 13 May 2024, Outlook Therapeutics announced that it submitted a Marketing Authorisation Application (MAA) in the UK for its ophthalmic formulation of bevacizumab (ONS-5010, LYTENAVA™) for the treatment of wet AMD. Outlook Therapeutics is seeking to achieve FDA, EU and MHRA approval for the launch of bevacizumab as the first approved ophthalmic formulation of bevacizumab, which has been used off label for ophthalmic conditions for many years. Outlook Therapeutics suggests that approval may also be sought in Japan, other EU markets, and elsewhere.
The UK submission follows the positive opinion for LYTENAVA™ issued by the EU’s Committee for Medicinal Products (CHMP) on 22 March 2024. The International Recognition Procedure allows MHRA to accelerate the assessment of new medicines by taking into account pre-existing approvals from the European Union, Australia, Canada, Japan, Switzerland, Singapore and/or the United States.