FDA accepts Biologics License Application (BLA) under priority review for faricimab for treatment of wet age-related macular degeneration and diabetic macular oedema

Faricimab is a bispecific antibody that targets 2 distinct pathways, angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A), that drive a number of retinal conditions. European Medicines Agency has also validated Marketing Authorization Application submission.

SPS commentary:

The BLA submission is based on positive results across four Phase III studies, which showed that faricimab, given at intervals of up to four months, offered non-inferior vision gains compared with aflibercept, given every two months.

Biospace Inc.