The European Medicines Agency has begun reviewing Outlook Therapeutics’s EU marketing authorization application (MAA) for what could become the first on-label ophthalmic formulation of bevacizumab (ONS-5010) to treat wet age-related macular degeneration (wet AMD).
In addition, the agency has accepted for review MAAs for exagamglogene autotemcel (exa-cel), Vertex Pharmaceuticals/CRISPR Therapeutics’ CRISPR/Cas9 gene edited therapy for sickle cell disease or transfusion-dependent beta thalassemia, and lecanemab,