ESSEX BIO-TECH (01061) and HENLIUS have jointly developed the licensed product AURA-2 for the treatment of exudative (wet) age-related macular degeneration. Phase III clinical studies have reached the primary endpoint.

ESSEX BIO-TECH (01061) announced that the results of the multicenter Phase III clinical study (AURA-2) of the anti-VEGF ophthalmic injection biopharmaceutical (HLX04-O) for the treatment of wet AMD patients have met the primary study endpoint. AURA-2 is a multicenter, randomized, double-blind, positive-controlled non-inferiority Phase III clinical study designed to compare the efficacy and safety of HLX04-O with ranibizumab intravitreal injection (IVT) in the treatment of wet AMD patients. Patients were randomly assigned in a 1:1 ratio to receive HLX04-O (1.25 mg) or ranibizumab (0.5 mg) IVT every four weeks, with treatment continuing for one year unless death, withdrawal of informed consent, loss to follow-up, or study discontinuation by the sponsor occurred. The primary study endpoint of this study was the average change in best-corrected visual acuity (BCVA) from baseline at week 36, with key secondary endpoints being the average change in BCVA from baseline at week 48, as well as other efficacy, safety, tolerability, and pharmacokinetic endpoints. The results showed that the average change in BCVA from baseline at weeks 36 and 48 in the HLX04-O group was non-inferior to the ranibizumab group, meeting the primary and key secondary study endpoints. Additionally, the overall, ocular, and non-ocular safety profiles of HLX04-O were similar to ranibizumab in wet AMD patients, with a good safety profile. HLX04-O is a new ophthalmic formulation product developed based on HENLIUS' independently developed Hanbeite (bevacizumab injection) by optimizing the prescription, specifications, and production process for ophthalmic use. It is intended for the treatment of wet AMD while maintaining the active ingredient unchanged.