Once every 3 months! The new generation of Novartis ophthalmic drug beovu has been approved by the European Union to treat wet age-related macular degeneration (wet AMD)!

-Novartis recently announced that the European Commission (EC) has approved the new generation of ophthalmic drug beovu (brolucizumab, also known as rth258) for the treatment of wet age-related macular degeneration (wet AMD, also known as neovascular AMD, namd) This approval applies to all 27 EU Member States, as well as the UK, Iceland, Norway and Liechtenstein In the European Union, an estimated 1.7 million people are affected by wet AMD, which is the main cause of severe vision loss and blindness in people over 65 years old Beovu is a new generation of anti vascular endothelial growth factor (VEGF) drug, which was approved to treat wet AMD in October 2019 in the United States It is worth mentioning that Novartis has used a priority review voucher (PRV) to accelerate the U.S regulatory review of beovu, reducing its review cycle from the regular 10 months to 6 months In January 2020, beovu was also approved by Swiss healthcare and Australia Novartis is committed to bringing beovu to patients around the world and is currently under review by regulators in Canada, Japan and Brazil Wet AMD is the main cause of blindness, affecting more than 20 million people around the world Frequent injection is a common reason for wet amd patients to give up treatment In the United States and the European Union, beovu is the first one to obtain regulatory approval, which can significantly reduce the retinal fluid compared with the eye product eylea (Aflibercept, abecept), and at the same time, in the eligible patients with wet AMD, during the 3-month loading period After treatment with anti VEGF drugs, which do not affect the curative effect every 3 months, we can improve the treatment compliance of patients by reducing the frequency of injection, so as to effectively maintain the vision of patients The current label of ophthalmic treatment products shows that once every 12 weeks (3 months) the efficacy of the regimen is poor Beovu is the first drug to provide less frequency of administration and maintain the effectiveness of treatment in the first year of treatment, which will give wet amd patients more time to focus on the important things in their lives Marie France Tschudin, President of Novartis pharmaceuticals, said: "wet amd patients tend to be elderly and may face major challenges in managing disease We believe that beovu and its ability to reduce retinal fluid will bring great therapeutic value and help doctors optimize the treatment of patients according to disease activity With the approval of this innovative biologics, Novartis is continuing to reimagine treatment options for patients with wet AMD " Wet amd (wet AMD, retinaboston Com) approval is based on data from phase III hawk study (nct02307682) and harrier study (nct02434328) These two studies are the first and only global head-to-head clinical studies that prospectively confirm that beovu has significant efficacy in starting treatment with a 12-week (3-month) dose regimen Both studies were prospective, randomized, double-blind, multicenter, and were conducted in patients with wet AMD to assess the efficacy and safety of beovu relative to eylea In two studies, eligible patients were given maintenance treatment at 3-month intervals immediately after the loading period The results showed that the two studies reached the main end point In the first year of treatment (week 48), the effect of beovu (6mg) on improving vision was not inferior to that of eylea The specific data were as follows: in the hawk study and harrier study, the average change of BCVA in the beovu (6mg) treatment group was 6.6 letters (6.8 letters in the eylea treatment group) and 6.9 letters, respectively (7.6 letters in the treatment group of eylea) In the two studies, about 30% of patients in the beovu treatment group had BCVA increased by at least 15 letters in one year of treatment In addition, beovu (6mg) also showed advantages in three secondary endpoints of key indicators of disease progression: disease activity, central visual field retinal thickness, retinal fluid (intraretinal fluid and / or subretinal fluid) The specific data were as follows: (1) at the 16th week and the 1st year of treatment, the proportion of patients with disease activity in the beovu (6mg) treatment group was lower than that in the eyla treatment group (at the 16th week [hawk study: 24.0% vs 34.5%, P = 0.001; Harrier study: 22.7% vs 32.2%, P = 0.002]; at the 1st year [hawk study: 23.5% vs 33.5%, P = 0.002; harrier study: 21.9% vs 31.4%, P = 0.002]; (2) at week 16 and year 1, the proportion of patients with intraretinal fluid (IRF) and / or subretinal fluid (SRF) in the beovu (6mg) treatment group was significantly lower than that in the eylea treatment group (35% reduction in both the hawk study and the Harrier study at week 16; 30% reduction in the hawk study and 41% reduction in the Harrier study at year 1) (3) At the first year of treatment, compared with the eylea group, the central visual field retinal thickness in the beovu group was also significantly reduced compared with the baseline (hawk study: LS average - 172.8 μ m vs - 143.7 μ m, P = 0.001; harrier study: LS average - 193.8 μ m vs - 143.9 μ m, P < 0.001) The results of anatomical retinal fluid showed that beovu was superior to eylea In addition, in the first year, more than half of the patients in the beovu (6mg) treatment group maintained a 3-month interval (hawk study 56%, harrier study 51%) In the first year, patients in the beovu (6mg) treatment group who started the 3-month regimen after the loading period had a probability of maintaining this interval of treatment time of 85% (hawk study) and 82% (harrier) In the study, the security of beovu is equivalent to that of eylea in general The active component of beovu is brolucizumab (rth258), a humanized single chain antibody fragment (scFv) targeting all types of vascular endothelial growth factor-A (VEGF-A) ScFv fragments have attracted great attention in drug development due to their small size, enhanced tissue permeability, rapid clearance of systemic circulation and drug delivery characteristics Brolucizumab's innovative structure makes it only 26 kDa in size It has a strong inhibitory effect on all subtypes of VEGF-A and has a high affinity In preclinical studies, brocizumab inhibited VEGF receptor activation by blocking ligand receptor interaction The increased VEGF pathway signal is related to pathological ocular angiogenesis and retinal edema In patients with chorioretinal vascular disease, inhibition of VEGF pathway can inhibit the growth of neovascularization, alleviate retinal edema and improve vision.