Efficacy and safety of intravitreal HLX04-O, an anti-VEGF monoclonal antibody, for the treatment of wet age-related macular degeneration

Abstract

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 of 1.25 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 255 µm) 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. Large-scale studies are required to confirm the outcomes.

Keywords: HLX04; HLX04-O; anti-vascular endothelial growth factor; bevacizumab; wet age-related macular degeneration.

Figure 1. Optical coherence tomography images of the affected eye during treatment with intravitreal HLX04-O injections

Yellow arrows indicate subretinal fluid. Numbers and line segments (in red) indicate macular center point thickness.

Figure 2. Changes during treatment with intravitreal HLX04-O injections

A: Macular center point thickness; B: BCVA letter score. BCVA: Best-corrected visual acuity; ETDRS: Early Treatment Diabetic Retinopathy Study.