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ARTICLE | Clinical News

Novartis' wet AMD therapy non-inferior to Eylea

June 23, 2017 8:37 PM UTC

Novartis AG (NYSE:NVS; SIX:NOVN) reported data from the 96-week Phase III HAWK and HARRIER trials in a total of over 1,800 patients with neovascular wet age-related macular degeneration (AMD) showing that intravitreal brolucizumab (RTH258) met the primary endpoint in both trials of non-inferiority to 2 mg Eylea aflibercept in the mean change from baseline to week 48 in best corrected visual acuity (BCVA). Brolucizumab also met the secondary endpoint in both trials of non-inferiority to Eylea in the mean change from baseline in BCVA over weeks 36-48.

HAWK evaluated 3 and 6 mg doses of brolucizumab and HARRIER evaluated only the 3 mg dose of brolucizumab. All 3 doses met the endpoints. Following a 3-month loading period, patients in the brolucizumab arms received the product every 3 months with an option to adjust to every 2 month dosing based on disease activity assessments. In HAWK and HARRIER, 57% and 52% of patients receiving brolucizumab, respectively, were maintained exclusively on every 3 month dosing following the loading period through week 48. Eylea’s label recommends every 2 month dosing following a 3-month loading period...

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