China partners Henlius and Essex Bio have filed for approval in their homeland for HLX04-O, a bevacizumab ophthalmic injection for wet age-related macular degeneration (wAMD), based on positive Phase III trial results showing non-inferiority to ranibizumab in visual acuity improvement at 48 weeks. The reformulated version of the biosimilar demonstrated comparable safety profiles in the 388-patient study, with similar ocular and systemic adverse event rates between treatment arms.

HLX04-O blocks VEGF-driven neovascularisation through weekly intravitreal injections. A parallel global Phase III trial is ongoing across China, Australia, the US and EU. wAMD accounts for 90% of AMD-related blindness globally, affecting 30 million patients. The submission positions HLX04-O as a potential cost-effective alternative to existing anti-VEGF therapies in China's rapidly growing ophthalmic market, where ageing populations are driving increased demand for retinal treatments.

PharmCube's NextBiopharm® database lists eight bevacizumab products approved for wAMD, with two more contenders in the global pipeline. Click here to request a free trial for NextBiopharm®.