Novartis launches new generation of eye drug Beovu (brolucizumab) in US

, Novartis, the swisspharmaceutical(http://giant, announced the launch of a new generation of ophthalmicdrug(http://Beovu (http:// in the United States to treat wet age-related macular degeneration (wet-AMD, also known as neophyte AMD, nAMD)Beovu (brolucizumab, RTH258) was approved by theFDA(http://earlier this month,Beovu,based on data from the Phase III HAWK study (NCT02307682) and the HARRIER study (NCT02434328)These two studies were the first and only global head-to-head clinical studies in wet-AMD patients that have been able to demonstrate significant efficacy in Beovu's initiation treatment with a 12-week (3-monthly) administration programmeBoth studies were prospective, randomized, double-blind, multicenter studies conducted in wet-AMD patients and assessed the efficacy and safety of Beovu relative to Eyleain2 studies, eligible patients were given maintenance therapy at 3 months' interval immediately after the load periodIn the first year, more than half of patients maintained a three-month interval (HAWK 56%, HARRIER 51 percent), and the rest were treated according to the 2-month interval 　　The results showed that in the first year of treatment (week 48), Beovu (6mg) was not as effective as Eylea in improving vision, with the average change of 6.6 letters (Eylea) in the HAWK study and the HARRIER study, the best corrective vision (BCVA) relative to the baseline of the Beovu (6mg) treatment group (Eylea treatment group 6.8 letters) and 6.9 letters (Eylea) 2 studies, about 30 percent of patients increased BCVA by at least 15 letters during the year of treatment 　　Beovu (6mg) also has advantages in the three secondary endpoints of key indicators of disease progression: disease activity, central field of view retinal thickness, retinal fluid (intra-retina fluid and/or retinal fluid) specific data are: (1) in the 48th week of treatment, the proportion of patients with disease activity in the Beovu (6mg) treatment group was lower than in the Eylea treatment group (HAWK study: 23.5% vs 33.5%, p.0022; HARRIER study: 21.9% vs 31.4%, p.0022
); 2) In the 48th week of treatment, the key markers of the retinal fluid in the Beovu (6mg) treatment group were significantly reduced compared to the Eylea treatment group: 31% (p 0.0001) in the HAWK study and 26% (p 0.0001) in the proportion of patients with retinal fluid (IRF) and/or retinal fluid (SRF) 　　In preclinical studies, brolucizumab inhibited the activation of VEGF receptors by blocking ligand-receptor interactions Increased VEGF pathway signals are associated with pathological eye angiogenesis and retinal edema In patients with retinoid vascular disease of the vein membrane, inhibiting the VEGF pathway can inhibit the growth of new vascular lesions, relieve retinal edema and improve vision