Novartis presents new data on ophthalmic drugs at EURETINA

Swiss pharma giant Novartis (NOVN: VX) on Sunday announced a new data analysis showing that retinal fluid was detected less often in patients treated with brolucizumab (RTH258) 6mg 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 18th Congress of the European Society of Retina Specialists (EURETINA) 2018 as a follow-up to data presented in November 2017.

The data show that brolucizumab 6mg 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 is the active ingredient of Regeneron (Nasdaq: REGN) and Bayer’s (BAYN: DE) Eylea, which is a direct competitor in the AMD market that is expected to reach a value of some $11.5 billion across the seven major markets by 2026, according to GlobalData.