Swiss pharma giant Novartis (NOVN: VX) has announced additional brolucizumab Phase III results from year two that reaffirmed its positive year one findings.
Brolucizumab met its primary endpoint of non-inferiority versus aflibercept – Bayer’s (BAYN: DE) Eylea - in best corrected visual acuity (BCVA) and exhibited superiority in key retinal outcomes at year one (48 weeks). Secondary endpoints at year two (96 weeks) reaffirmed superiority of brolucizumab 6mg in reduction of retinal fluid, an important marker of disease activity in patients with neovascular age-related macular degeneration (nAMD). Approximately 20 to 25 million people are affected by nAMD, also known as wet AMD, a leading cause of blindness worldwide.
The year two HAWK and HARRIER findings demonstrated that fewer patients with nAMD had intra-retinal fluid (IRF) and/or sub-retinal fluid (SRF) - key markers used by physicians to determine injection frequency in clinical practice - with brolucizumab 6mg versus aflibercept at week 96 [24% for brolucizumab 6mg versus 37% for aflibercept in HAWK (P=0.0001); 24% vs 39%, respectively, in HARRIER (P<0.0001)].
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