Background：Brolucizumab is the first and only single-chain variable fragment scFv targeting vascular endothelial growth factor VEGF-A. It has a smaller molecular weight 26 kDa. The mAb is undergoing evaluation as a treatment for neovascular age-related macular degeneration nAMD. In June 2017, Novartis announced that the primary efficacy endpoint of non-inferiority to aflibercept EYLEA® in mean change in best-corrected visual acuity from baseline to week 48 was met in the Phase 3 HAWK NCT02307682 and HARRIER NCT02434328 studies, which included more than 1,800 patients. The two studies compared the efficacy and safety of intravitreal injections of 6 mg brolucizumab or 3 mg brolucizumab HAWK study only versus 2 mg aflibercept in patients with nAMD. Of patients receiving 6 mg brolucizumab, 57% HAWK and 52% HARRIER were maintained exclusively on an every 12 week dosing interval immediately following the loading phase and continuing through week 48.54 Key secondary endpoints were also met. Novartis is developing a competitive, low cost of goods formulation, and expects to complete the PK study with antibody derived from the final manufacturing process to enable filing in 2018.
