New analysis of Novartis Phase III brolucizumab (RTH258) data reinforces superior reduction of retinal fluid, a key marker of disease activity in nAMD

Pre-specified analysis provides insight into maintenance treatment effectiveness with like-for-like comparison of brolucizumab versus aflibercept over entire week 36 to 48 treatment period

Retinal fluid was detected less often in patients treated with brolucizumab 6 mg versus aflibercept between weeks 36 to 48
Regulatory submissions for brolucizumab on track for December 2018

Basel, 22 September 2018 – 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.

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)[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…..

Read more :https://globenewswire.com/news-release/2018/09/22/1574587/0/en/New-analysis-of-Novartis-Phase-III-brolucizumab-RTH258-data-reinforces-superior-reduction-of-retinal-fluid-a-key-marker-of-disease-activity-in-nAMD.html

Source: Novartis International AG

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