ESSEX BIO-TECH: The Phase III clinical study results of the anti-VEGF ophthalmic injection biologic for the treatment of wet AMD in Chinese patients have reached the primary endpoint
ESSEX BIO-TECH announced that its anti-VEGF ophthalmic injection biologic HLX04-O for the treatment of wet AMD has achieved its primary endpoint in the Phase III clinical study AURA-1. The results showed that the improvement in best-corrected visual acuity at week 48 with HLX04-O was comparable to that of Ranibizumab, and both had similar safety profiles. HLX04-O is a new ophthalmic formulation optimized based on Hanbeitai®, and the international multicenter Phase III clinical study AURA-2 is currently underway, expected to be completed in 2025
According to the Zhitong Finance APP, ESSEX BIO-TECH (01061) announced that the results of the Phase III clinical study (AURA-1) for the anti-VEGF ophthalmic injection biologic drug (HLX04-O) used to treat wet AMD patients in China have reached the primary endpoint.
AURA-1 is a multicenter, randomized, double-blind, positive-controlled non-inferiority Phase III clinical study aimed at comparing the efficacy and safety of HLX04-O with ranibizumab intravitreal injection (IVT) in treating newly diagnosed wet AMD patients. Enrolled patients were randomly assigned in a 1:1 ratio to receive HLX04-O (1.25 mg) IVT or ranibizumab (0.5 mg) IVT, administered once every four weeks, for a duration of one year, provided that the patients did not experience death, withdrawal of informed consent, loss to follow-up, or sponsor termination of the study. The primary endpoint of this study was the change in the average number of letters improved in best-corrected visual acuity (BCVA) from baseline at week 48, while secondary endpoints included other efficacy, safety, tolerability, and pharmacokinetic indicators. The results showed that the change in the average number of letters improved in BCVA at week 48 in the HLX04-O group was non-inferior to that in the ranibizumab group, achieving the primary endpoint. Additionally, HLX04-O and ranibizumab exhibited similar overall, ocular, and non-ocular safety profiles in wet AMD patients, demonstrating good safety.
HLX04-O is a new ophthalmic formulation product developed based on the independently developed Hanbeitai® (bevacizumab injection) by Fuhong Hanlin, optimized in terms of prescription, specifications, and production processes according to the needs of ophthalmic medication, while maintaining the same active ingredient, intended for the treatment of wet AMD.
In addition to achieving the primary endpoint in AURA-1, the international multicenter Phase III clinical study of HLX04-O in wet AMD patients is being conducted in an orderly manner in several European countries, Australia, the United States, and China (AURA-2), with the last patient visit scheduled to be completed in January 2025
