Essex Bio-Technology's HLX04-O meets primary endpoint in phase 3

Essex Bio-Technology Limited announced that the Phase 3 clinical study of its anti-VEGF ophthalmic injection bio-pharmaceutical product, HLX04-O, for treating wet age-related macular degeneration (AMD) in Chinese patients, met its primary endpoint. The AURA-1 study, a multi-centre, randomized trial comparing HLX04-O to ranibizumab, demonstrated that HLX04-O was non-inferior to ranibizumab in improving visual acuity at week 48, with a similar safety profile. The company notes that no bevacizumab product is currently approved for wet-AMD in the PRC, a market where sales of approved drugs for the condition reached RMB4.18 billion in 2024. An international multicentre phase 3 clinical study of HLX04-O in patients with wet-AMD (AURA-2) is ongoing successively in several European countries, Australia, the United States and the PRC with last patient last visit completed by January 2025.