New drug application for Aer Jian eye drug abicipar pegol accepted by FDA

recently, Allergan and partner Molecular Partners jointly announced that
thenew drug(http://application for the treatment of new blood vessels (wet) age-related macular degeneration (nAMD) by the http:// drug(http://) has been accepted by the U.SFood and Drug Administration (
FDA(http://and is expected to be reviewed in mid-2020About abicipar
abicipar is an angiogenesis drug based on DARPin technology developed for treatment of nAMD and DMEabicipar is an antagonist for vascular endothelial growth factor A (VEGF-A), which can effectively inhibit all relevant subtypes of VEGF-AAbicipar combines small size, high-potency, long half-life characteristics in glass body to provide lower injection frequencies (current standard nursing therapy compared to Lucentis) and higher vision gainBLA and MAA based on data from two head-to-head Phase III clinical studies (SEQUOIA, CEDAR), the results support the non-poor efficacy of abicipar's quarterly administration compared to roche/Novartis Lucentis (ranibizumab, Renizumab) monthly, which reduced the number of injections in the first year by more than 50% (6 vs 13)The SEQUOIA study and CEDAR studies compared the efficacy and safety of abicipar and ranibizumab in patients with previously untreated (initial treatment) nAMD results confirmed that, in week 52, abicipar 8 weeks (Q8) and 12 weeks (Q12) fixed interval treatment plan and ranibizumab 4 weeks (RQ4) interval administration treatment in stable vision (best corrective vision (BCVA) compared to the baseline vision loss of 15 letters) achieved the main end point of non-adverse effect 　　Abicipar injection 6 needles (Q12) and 8 injections (Q8) have similar results with ranibizumab injection s13 (RQ4 programme) treatment for one year: SEQUOIA study, Q8, Q12, R The proportion of patients with stable vision in qQ4 group was 94.8%, 91.3% and 96.0%, respectively, and in CEDAR study, the proportion of patients with stable vision in Q8 group, Q12 group and RQ 4 group was 91.7%, 91.2% and 95.5%, respectively 　　In terms of safety
overall adverse reactions were similar in the three treatment groups, and the incidence of intra-eye inflammation was higher in the abicipar treatment group: SEQUOIA study, Q8 group, Q12 group, RQ4 group, the overall treatment-related adverse event incidence rate was 78.3%, 78%, 74%, and the incidence of intra-eye inflammatory events was 15.7%, 15.3% and 0.6%, respectively CEDAR study, Q8, Q12, RQ4 groups, the overall treatment-related adverse events were 73.7%, 81.1%, 73.2%, and intra-eye inflammation events were 15.1%, 15.4% and 0%, respectively