Biotech Values

[DewDiligence]

NVS reports full dataset for RTH258-vs-Eylea phase-3 trials:

https://www.novartis.com/news/media-releases/novartis-brolucizumab-rth258-demonstrates-superiority-versus-aflibercept-key

Novartis…announced further positive results from two Phase III studies of brolucizumab [RTH258] versus aflibercept [Eylea]. Results showed non-inferiority in primary endpoint, superiority in key retinal health outcomes, and long-lasting effect in patients with neovascular age-related macular degeneration (nAMD), a leading cause of blindness. The results of the head-to-head trials, HAWK and HARRIER, were presented at the American Academy of Ophthalmology (AAO) 2017 Annual Meeting.

…At week 16, relative to aflibercept, 35% fewer brolucizumab 6 mg patients showed presence of IRF [intra-retinal fluid] and/or SRF [sub-retinal fluid] in HAWK, and 33% fewer in HARRIER (P<0.0001 for both). Again at week 48, relative to aflibercept, 31% fewer patients on brolucizumab 6 mg had IRF and/or SRF in HAWK, and 41% fewer in HARRIER (P<0.0001 for both). The absence of fluid for patients in the brolucizumab arm suggests the potential for a long-lasting effect and decreased treatment need.

…With brolucizumab, significantly fewer patients had active disease at week 16 in a matched head-to-head comparison. Active disease was observed in 23.5% of brolucizumab 6 mg patients versus 33.5% of aflibercept patients in HAWK, and in 21.9% of brolucizumab patients versus 31.4% of aflibercept patients in HARRIER (P=0.0022 for both).

As reported in Jun 2017 (#msg-132328161), both phase-3 trials met the primary endpoint of showing non-inferiority to Eylea in BCVA (Best Corrected Visual Acuity), the standard efficacy metric for AMD.