On 28 May 2024, Outlook Therapeutics announced it received EU marketing authorisation for LYTENAVATM (ONS-5010, bevacizumab-gamma) 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 EU. The marketing authorisation grants LYTENAVATM 10 years of EU market exclusivity.
Outlook Therapeutics reports that it is aiming for the first commercial launch of the product in an EU Member State in Q1/2025.
Outlook Therapeutics is also seeking approval for ophthalmic bevacizumab in the UK, with its MAA submitted on 13 May 2024, and the US, having resubmitted a BLA to the FDA in August 2022.