Novartis announced a new data analysis showing that
retinal fluid was detected less often in patients treated with brolucizumab
(RTH258) 6 mg versus aflibercept over four visits between weeks 36 to 48[1].
Retinal fluid is a key marker of disease activity in neovascular age-related
macular degeneration (nAMD)[2]. The data, from pre-specified secondary endpoints
of the Phase III HAWK and HARRIER trials[1], were presented at EURETINA 2018 as
a follow-up to data presented in November 2017.
retinal fluid was detected less often in patients treated with brolucizumab
(RTH258) 6 mg versus aflibercept over four visits between weeks 36 to 48[1].
Retinal fluid is a key marker of disease activity in neovascular age-related
macular degeneration (nAMD)[2]. The data, from pre-specified secondary endpoints
of the Phase III HAWK and HARRIER trials[1], were presented at EURETINA 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.
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)[1]. 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)[1]. Importantly, more than half of brolucizumab 6 mg patients were
maintained on q12w dosing until week 48.
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)[1]. 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)[1]. Importantly, more than half of brolucizumab 6 mg patients were
maintained on q12w dosing until week 48.
“Retinal fluid is an important marker of disease activity and the need for
treatment. These new data give physicians even more insight into the robustness
of the 48 week anatomical findings and support the overall impact brolucizumab
has on key measures of retinal fluid, including IRF/SRF, sub-retinal pigment
epithelial fluid and central subfield thickness,” said Dirk Sauer, Development
Unit Head, Novartis Ophthalmology. “These results were noted even while more
than half of brolucizumab 6 mg patients were receiving treatment every 12 weeks
at week 48, further reinforcing our confidence in brolucizumab’s superior fluid
resolution and supporting our goal of reimagining care for people with nAMD.”
treatment. These new data give physicians even more insight into the robustness
of the 48 week anatomical findings and support the overall impact brolucizumab
has on key measures of retinal fluid, including IRF/SRF, sub-retinal pigment
epithelial fluid and central subfield thickness,” said Dirk Sauer, Development
Unit Head, Novartis Ophthalmology. “These results were noted even while more
than half of brolucizumab 6 mg patients were receiving treatment every 12 weeks
at week 48, further reinforcing our confidence in brolucizumab’s superior fluid
resolution and supporting our goal of reimagining care for people with nAMD.”
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