Novartis announces FDA filing acceptance and Priority Review of brolucizumab (RTH258) for patients with wet AMD - Seite 2

Additionally, at week 48 in the studies, key secondary endpoint assessments showed significantly fewer brolucizumab patients with disease activity (23.5% of brolucizumab 6 mg patients versus 33.5% of aflibercept patients in HAWK, and 21.9% versus 31.4%, respectively, in HARRIER (P=0.0022 for both) as well as retinal fluid - key markers used by physicians to help guide management of the disease in clinical practice (31% fewer patients on brolucizumab 6 mg had intra-retinal fluid (IRF) and/or sub-retinal fluid (SRF) in HAWK, and 26% fewer in HARRIER, versus aflibercept (P<0.0001 for both)[5],[6].

"Wet AMD robs people of their precious sight and takes a major toll on the lives of millions of people who face not only vision loss, but also the burden of frequent injections into their eyes," said Dawn Prall George, executive director, The Support Sight Foundation. "We are always excited about potential new treatment options and hopeful they may help people manage this devastating disease."

About brolucizumab (RTH258)
Brolucizumab (RTH258) is a humanized single-chain antibody fragment (scFv) and the most clinically advanced, humanized single-chain antibody fragment to reach this stage of development. Single-chain antibody fragments are highly sought after in drug development due to their small size, enhanced tissue penetration, rapid clearance from systemic circulation and drug delivery characteristics[7-9].

The proprietary innovative structure results in a small molecule (26 kDa) with potent inhibition of, and high affinity to, all VEGF-A isoforms[7],[10]. In preclinical studies, brolucizumab inhibited activation of VEGF receptors through prevention of the ligand-receptor interaction[7],[9],[10]. Increased signaling through the VEGF pathway is associated with pathologic ocular angiogenesis and retinal edema[11]. Inhibition of the VEGF pathway has been shown to inhibit the growth of neovascular lesions, resolve retinal edema and improve vision in patients with chorioretinal vascular diseases[12].

About HAWK and HARRIER study design
With more than 1,800 patients across nearly 400 sites worldwide, HAWK (NCT02307682) and HARRIER (NCT02434328) are the first and only global head-to-head trials in patients with nAMD that prospectively demonstrated efficacy at week 48 using an innovative q12w/q8w regimen, with a majority of patients on q12w immediately following the loading phase[3-5]. Both studies are 96-week prospective, randomized, double-masked multi-center studies and part of the Phase III clinical development of brolucizumab[3],[4],[6].