Phase III clinical trials of brolucizumab in patients with neovascular age-related macular degeneration

Full article: https://novartis.gcs-web.com/static-files/ad93faf6-c1a9-47a1-899a-547a1b1c66f9

Open pdf (~4.6 mb): Phase III clinical trials of brolucizumab in patients with neovascular age-related macular degeneration

What is brolucizumab (also known as RTH258)?

• A unique, small (26 kDa), humanized, investigational single-chain antibody fragment, which is a potent inhibitor of vascular endothelial growth factor (VEGF) 1,2,3
• Abnormally high levels of VEGF are key in the development of neovascular age-related macular degeneration (nAMD), resulting in the formation of abnormal blood vessels in the retina and increased retinal thickness, due to fluid accumulation within or beneath the retinal layers 4
• nAMD is the leading cause of severe vision loss and legal blindness in people over the age of 65 in North America, Europe, Australia and Asia, impacting an estimated 20 to 25 million people worldwide 5,6
• The ecacy and safety of brolucizumab in patients with nAMD is being tested in two pivotal Phase III studies called HAWK and HARRIER 7,

HAWK and HARRIER

Study Overview

• HAWK and HARRIER are prospective, randomized, double-masked, 2-year ongoing studies to evaluate the ecacy and safety of brolucizumab for the treatment of nAMD:
• HAWK (NCT02307682) Began in December 2014 in study sites in North, Central, and South America, Israel, Australia, New Zealand and Japan. 7
• HARRIER (NCT02434328) Began in July 2015 across Europe and Asia. 8
• BOTH STUDIES have completed patient recruitment, enrolling >1800 over 400 PATIENTS STUDY SITES in total

Study Design

Two pivotal trials to test the ecacy and safety of intravitreal injections of brolucizumab 6 mg (HAWK and HARRIER) and brolucizumab 3 mg (HAWK only) versus aflibercept 2 mg in patients with nAMD

Overview: Brolucizumab (RTH258) for the treatment of wet age-related macular degeneration