Novartis' wet AMD therapy non-inferior to bi-monthly Eylea

Novartis AG (NYSE:NVS; SIX:NOVN) said brolucizumab (RTH258) was non-inferior to Eylea aflibercept on the primary and key secondary endpoints in two Phase III studies to treat wet age-related macular degeneration (AMD). In each study, more than half of patients receiving brolucizumab remained on a 12-week dosing schedule, suggesting that the therapy could offer an advantage over Eylea, whose label recommends dosing every eight weeks.

The primary endpoints of the 96-week HAWK and HARRIER studies measured mean change from baseline to week 48 in best corrected visual acuity (BCVA), while the key secondary endpoint tested mean change over weeks 36-48. Novartis said 6 mg brolucizumab met the endpoints with “highly significant” p-values. HAWK evaluated a 3 mg brolucizumab dose, which also met both endpoints. The trials included a total of more than 1,800 patients...