Application for FDA approval for supplementary biologics for wet age macular degeneration injection EYLEA

AMD is a common age-related eye disease common lying in people over 50 years of age and is the leading cause of vision loss and irreversible vision lossrecently, Regeneron Pharmaceuticals announced that its application for license to supplement biologics (sBLA) for the wet age macular degeneration (wAMD) injection EYLEA (sBLA) has been approved by theFDA
this approval is based on EYLEA's Phase 3Testfor Wet AMD (1 and VIEW 2 data in the second year)Patients who participated in the trial received an improved administration programme of 12 weeks (at least every 12 weeks) and given additional doses as neededThis test data has been updated in the EYLEA labeleYLEA
EYLEA is an eye injection with a primary component of vascular endothelial growth factor (VEGF) inhibitorsIts mechanism of action is to block the growth factor VEGF-A and placental growth factor (PLGF) involved in vascular production, which in turn blocks the production of new blood vessels and reduces intra-eye vascular permeabilityBOTH VIEW 1 AND VIEW 2 WERE PHASE 3 RANDOMIZED DOUBLE-BLIND CLINICAL TRIALS FOR WET AMD, WITH 2,419 PATIENTS FROM THE UNITED STATES AND SEVERAL EUROPEAN COUNTRIES RANGING FROM 49 TO 99 YEARS OF AGE (AVERAGE AGE 76) FOR A TRIAL DURATION OF 52 WEEKSThe trials were divided into four groups, receiving 2 mg OfEYLEA once a month, continuing to receive doses every eight weeks after three months, 2 mg EYLEA per month, 0.5 mg EYLEA once a month, and ranibizumab once a monthIn both trials, the primary end point was the proportion of patients who maintained vision, defined as a reduction in visual asensitivity of less than 15 letters in the 52-week period compared to the baselineresults showed that the efficacy, safety and tolerance of both trials were good, with about 94% of THE PATIENTs in the VIEW 1 trial maintaining vision after one year and the view 2 trial patients maintaining vision about 95% after one year