Tags : Brolucizumab

Novartis Reports Results of Beovu (brolucizumab) in Two New Post-Hoc

Shots: The P-III HAWK (6/3mg) & HARRIER (6mg) study assessing Beovu [q12w/q8w with the majority on q12w following the loading phase) vs aflibercept (2mg) in 1,800 patients with wet AMD across 400 centers Results: first analysis ewer patients had early persistent fluid (12.5% vs 20.4%), defined as the presence of intra-retinal fluid or subretinal fluid […]Read More

Novartis’ Beovu (brolucizumab) Receives EMA’s Approval for its Safety Label

Shots: The EU label update includes additional categorization of retinal vasculitis and/or retinal vascular occlusion, usually in the intraocular inflammation. The approval follows Novartis completion of safety review and initiation of update to the Beovu prescribing information globally The label update is applicable to all 27 EU member states as well as UK, Iceland, Norway, […]Read More

Novartis’ Beovu (brolucizumab) Receives FDA’s Approval for the Treatment of

Shots: The approval is based on P-III HAWK (NCT02307682) & HARRIER (NCT02434328) studies involves assessing of Beovu (intravitreal injection), 6mg (HAWK and HARRIER) & 3mg (HAWK) vs Aflibercept (2mg) in 1,800+ patients with wet AMD across 400 centers globally The P-III studies demonstrated non-inferiority in mean change BCVA @1yr. (week 48); reductions in central subfield […]Read More

Novartis Reports FDA’s Acceptance of BLA for Brolucizumab (RTH258) to

Shots: The BLA submission is based on P-III HAWK and HARRIER study results assessing brolucizumab (3/6 mg, q12w/q8w) vs aflibercept in 1800 patients with neovascular age-related macular degeneration nAMD or wet AMD at 400 sites P-III HAWK and HARRIER: @48wks. best-corrected visual acuity (BCVA) from baseline (6.6, 6.9 letters vs 6.8, 7.6 letters); patients with […]Read More