Shots:

• The EC’s approval is based on P-III HAWK (6/3mg) & HARRIER (6mg) study assessing Beovu [q12w/q8w with the majority on q12w following the loading phase) vs aflibercept 2 mg in 1-800 patients with wet AMD across 400 centers
• The two P-III studies resulted in meeting its 1EPs i.e. gain in BCVA @48wks.- it demonstrated superior resolution of retinal fluid (IRF/SRF) (for 6mg (31% & 26% vs 45% & 44%)- superfluid resolution @16wks. & 1yr.- maintenance of 3mos. dosing interval @1yr. (56% & 51%) respectively
• Beovu (RTH258) is the only anti-VEGF therapy approved in the EU for wet AMD offering the option to start eligible patients on 3mos. dosing intervals immediately after the loading phase. The approval is applicable to all 27 EU states including the UK- Iceland- Norway- and Liechtenstein

Click here ­to­ read full press release/ article | Ref: Novartis | Image: WSJ