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 disease activity (23.5%- 21.9% vs 33.5%- 31.4%); key markers used by physicians to help guide management of the disease (31%- 26%)
• Brolucizumab (RTH258) is a single-chain antibody fragment (scFv) that inhibits VEGF receptors- with its expected launch in end of 2019. Novartis has utilized its Priority Review Voucher for brolucizumab’s FDA review

| Ref: Novartis | Image: Business Journal