FIELD : medicine. SUBSTANCE : group of inventions relates to immunology. Humanised monoclonal human anti-factor D antibody or its antigen-binding fragment, its nucleotide sequence, cell and vector, which carry these antibodies are disclosed, as well as a method for its production and use to obtain compositions for the treatment of diseases and disorders associated with excessive or uncontrolled activation of the complement system. Anti-factor D antibody or an antigen-binding fragment thereof comprises (I) a light chain variable domain containing an amino acid sequence with at least 97? identity with SEQ ID NO : 5, and a heavy chain variable domain containing an amino acid sequence with at least 97? identity with SEQ ID NO : 6; or (II) a light chain variable domain containing an amino acid sequence with at least 97? identity with SEQ ID NO : 7, and a heavy chain variable domain containing an amino acid sequence with at least 97? identity with SEQ ID NO : 8; or (III) a light chain variable domain containing an amino acid sequence with at least 97? identity with SEQ ID NO : 9, and a heavy chain variable domain containing an amino acid sequence with at least 97? identity with SEQ ID NO : 10; or (IV) a light chain variable domain containing an amino acid sequence with at least 97? identity with SEQ ID NO : 11, and a heavy chain variable domain containing an amino acid sequence with at least 97? identity with SEQ ID NO : 12. Method for producing an anti-factor D antibody or an antigen-binding fragment thereof includes culturing a host cell comprising an expression vector carrying a nucleic acid encoding an antibody or its antigen-binding fragment. EFFECT : composition comprising an antibody or antigen-binding fragment thereof, suitable for the treatment of disorders mediated by the complement system, where the disorder is an eye disease such as age-related macular degeneration or diabetic retinopathy. 14 cl, 13 dwg, 4 tbl, 6 ex