New data reinforces superior reduction of retinal fluid, a key marker of disease activity in age-related macular degeneration. Novartis

Novartis announced a new data analysis showing that retinal fluid was detected less often in patients treated with brolucizumab (RTH 258) 6 mg versus aflibercept over four visits between weeks 36 to 48. Retinal fluid is a key marker of disease activity in neovascular age-related macular degeneration (nAMD). The data, from pre-specified secondary endpoints of the Phase III HAWK and HARRIER trials, were presented at EURINA 2018 as a follow-up to data presented in November 2017.

The data show that brolucizumab 6 mg had superior fluid resolution versus aflibercept over four visits during weeks 36 to 48. The 36- to 48- week analysis is noteworthy because it provides insight into the effect of maintenance treatment, an important clinical focus for a chronic disease like nAMD. Additionally, the analysis accounts for dosing interval differences between the two medicines. Due to the unique design of the HAWK and HARRIER trials, brolucizumab patients were dosed at various intervals, namely q12w with some adjusted to q8w based on disease activity. Aflibercept patients were dosed at q8w, per the label at the time of trial initiation. In the pre-specified secondary analyses for weeks 36 to 48, patients treated with brolucizumab 6 mg in the HAWK and HARRIER trials had significantly fewer visits in which intraretinal fluid (IRF)/subretinal fluid (SRF) was observed. In HAWK, 47.5% of patients treated with brolucizumab 6 mg q12w or adjusted to q8w had no visits in which IRF/SRF was detected, compared to 42.5% of aflibercept patients (P=0.0012, reflecting distribution across all visits during weeks 36 through 48. In HARRIER, 53% of patients treated with brolucizumab 6 mg had no visits in which IRF/SRF was detected, compared to 45.5% of aflibercept patients (P=0.0001, reflecting distribution across all visits during weeks 36 through 48. Importantly, more than half of brolucizumab 6 mg patients were maintained on q12w dosing until week 48.

As previously announced, HAWK and HARRIER achieved their primary endpoints of non-inferiority in mean change in best corrected visual acuity (BCVA) at week 48 with brolucizumab versus aflibercept. The key pre-specified secondary endpoint of non-inferiority in mean change in BCVA between weeks 36 and 48 was also met.