(RTTNews.com) - Novartis ( NVS ) 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 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 6 mg 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 6 mg versus aflibercept at week 96 [24% for brolucizumab 6 mg vs. 37% for aflibercept in HAWK (P=0.0001); 24% vs. 39%, respectively, in HARRIER (P<0.0001)].
Additionally, brolucizumab 6 mg patients continued to demonstrate reductions in central subfield thickness (CST) at week 96. An increase in CST in nAMD is an important measure of abnormal fluid accumulation and edema and may result in reduced vision. Absolute reductions in CST from baseline were -175 ?m for brolucizumab 6 mg versus -149 ?m for aflibercept in HAWK (P=0.0057) and -198 ?m versus -155 ?m, respectively, in HARRIER (P<0.0001).
Also at week 96, fewer brolucizumab 6 mg patients had sub-retinal pigment epithelium (sub-RPE) fluid (11% for brolucizumab 6 mg vs. 15% for aflibercept in HAWK; 17% vs. 22%, respectively, in HARRIER. Additionally, of the patients on brolucizumab 6 mg who successfully completed year one on a 12-week dosing interval, 82% in HAWK and 75% in HARRIER were maintained on a 12-week dosing interval in year two.
As previously announced, HAWK and HARRIER met their primary endpoint of non-inferiority in mean change in BCVA at week 48 with brolucizumab versus aflibercept. Brolucizumab maintained robust visual gains in year two, with mean change in BCVA of 5.9 letters for brolucizumab 6 mg versus 5.3 letters for aflibercept in HAWK, and 6.1 letters versus 6.6 letters, respectively, in HARRIER.
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