The Board of Essex Bio-Technology Limited announced that the first patient in the United States has recently been dosed in an international multi-centre phase 3 clinical study for recombinant anti-vascular endothelial growth factor humanised monoclonal antibody ophthalmic injection HLX04-O for the treatment of wet-AMD. The phase 3 clinical study is a randomised, double-blinded, active-controlled and global study conducted in patients with wet-AMD, which aims to compare the efficacy and safety of HLX04-O with that of ranibizumab. Eligible patients will be randomly divided into two groups at a ratio of 1:1 to receive intravitreal injection of HLX04-O (1.25 mg) or ranibizumab (0.5 mg) every four weeks for 48 weeks.

The primary objective of this study is to compare the efficacy of HLX04-O with that of ranibizumab at week 36 in patient's study eye with wet-AMD. The primary endpoint is the mean change from baseline in the best-corrected visual acuity (BCVA) at week 36. The secondary objectives include the evaluation of other efficacy endpoints, safety, tolerability and pharmacokinetic profiles.