This single-arm, open-label, multicentre, phase I/II study aimed to evaluate the safety and preliminary efficacy of EB12-20145P (HLX04-O) via intravitreal injection (IVT) in patients with active wet age-related macular degeneration (wAMD). The study consisted of two parts. Part 1 was a safety run-in stage which enrolled 6 patients. Part 2 was a single-arm, open-label, multicentre, phase II study and 20 patients (including 6 patients from part 1) were enrolled in this part. All patients received EB12-20145P (HLX04-O) IVT (1.25 mg/0.05 mL) every four weeks until death, withdrawal of informed consent, loss to follow-up, study termination by sponsor, or completion of one-year treatment. For part 1, the primary endpoint was safety event related to EB12-20145P (HLX04-O) that occurred within four weeks after the first dose of EB12-20145P (HLX04-O); secondary endpoints were the systemic pharmacokinetic characteristics of EB12-20145P (HLX04-O) after the first and fourth IVT administration. For part 2, the primary endpoint was the mean change of letters from baseline in best corrected visual acuity (BCVA) at week 12; secondary endpoints included other efficacy measures, safety, immunogenicity, and systemic pharmacokinetic characteristics. The results showed that EB12-20145P (HLX04-O) was safe and well tolerated in wAMD patients, and preliminary efficacy was observed.
EB12-20145P (HLX04-O) is a recombinant anti-VEGF humanized monoclonal antibody injection constructed using genetic engineering technology independently developed by Henlius. EB12-20145P (HLX04-O) can inhibit VEGF's binding to its receptor Flt-1 (VEGFR-1) and KDR(VEGFR-2) on endothelial cells to inhibit the activation of its tyrosine kinase signalling pathway, inhibit endothelial cell proliferation and reduce angiogenesis, thereby treating eye diseases associated with angiogenesis. According to the requirements of ophthalmic drugs, Henlius has developed EB12-20145P (HLX04-O) which optimizes the prescription, specifications, and production processes of HANBEITAI, assuming that the active ingredients remain unchanged. Through a series of comparability analysis, it is proved that the changes in the production process and prescription of the preparation have no adverse impact on the quality, safety and efficacy of the preparation.
As of now, the clinical trial applications of EB12-20145P (HLX04-O) had been approved in
About wAMD
Age-related macular degeneration is one of the leading causes of visual impairment and blindness in the elderly worldwide[1]. According to the
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Reference
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