·AIM:To evaluate the efficacy and safety of HLX04-O,an investigational ophthalmic formulation of HLX04(bevacizumab biosimilar)for intravitreal injection,as a treatment for wet age-related macular degeneration(wAM...·AIM:To evaluate the efficacy and safety of HLX04-O,an investigational ophthalmic formulation of HLX04(bevacizumab biosimilar)for intravitreal injection,as a treatment for wet age-related macular degeneration(wAMD)in a phase 1/2 clinical trial(NCT04993352).·METHODS:Eligible patients with wAMD were enrolled to receive HLX04-O intravitreal injections at a dose of1.25 mg/0.05 mL every four weeks.Efficacy and adverse events were evaluated every month during study visits.·RESULTS:A 76-year-old male with wAMD in his left eye participated in the trial and completed six cycles of HLX04-O intravitreal injections.Changes were observed in macular center point thickness(baseline vs last study visit,437 vs 255μm)and best-corrected visual acuity letter score(baseline vs last study visit,36 vs 77)of the affected eye,which indicated an improvement in wAMD over treatment.No adverse events were reported by the data cutoff date.·CONCLUSION:HLX04-O at 1.25 mg/0.05 mL every four weeks is well tolerated in this patient,demonstrating promising safety and efficacy in wAMD treatment.Largescale studies are required to confirm the outcomes.展开更多
文摘·AIM:To evaluate the efficacy and safety of HLX04-O,an investigational ophthalmic formulation of HLX04(bevacizumab biosimilar)for intravitreal injection,as a treatment for wet age-related macular degeneration(wAMD)in a phase 1/2 clinical trial(NCT04993352).·METHODS:Eligible patients with wAMD were enrolled to receive HLX04-O intravitreal injections at a dose of1.25 mg/0.05 mL every four weeks.Efficacy and adverse events were evaluated every month during study visits.·RESULTS:A 76-year-old male with wAMD in his left eye participated in the trial and completed six cycles of HLX04-O intravitreal injections.Changes were observed in macular center point thickness(baseline vs last study visit,437 vs 255μm)and best-corrected visual acuity letter score(baseline vs last study visit,36 vs 77)of the affected eye,which indicated an improvement in wAMD over treatment.No adverse events were reported by the data cutoff date.·CONCLUSION:HLX04-O at 1.25 mg/0.05 mL every four weeks is well tolerated in this patient,demonstrating promising safety and efficacy in wAMD treatment.Largescale studies are required to confirm the outcomes.
