Novartis’ Beovu Achieves Faster and Sustained Retinal Fluid Control Compared to Eylea in Wet AMD Patients
Jul 28, 2020 17:15
CST Updated
17:05
Novartis
Drug Development and Manufacturing
July 28, 2020 News /BioValleyBIOON/ --Novartis(Novartis) recently announced the results of a new post-hoc analysis from the pivotal Phase III HAWK and HARRIER trials of its next-generation ophthalmic drug, Beovu (brolucizumab). The data showed that in patients with wet age-related macular degeneration (wet-AMD), treatment with Beovu achieved sustained retinal fluid control more rapidly compared to Eylea (aflibercept).
Retinal fluid is a key marker of disease activity in wet AMD, and achieving a dry retina is the core treatment goal. Sustained dryness is defined as the absence of retinal fluid (no intraretinal fluid [IRF] and no subretinal fluid [SRF]) at three or more consecutive visits during the 96-week treatment period.
Analysis showed that in two trials, the Beovu group achieved sustained dryness in ≥50% of patients more rapidly than the Eylea group. Specifically, in the HAWK and HARRIER trials, the Beovu group reached this target within 8 weeks and 4 weeks, respectively, whereas the Eylea group achieved it within 12 weeks and 8 weeks, respectively.
Furthermore, the Beovu group achieved sustained dryness in ≥75% of patients more rapidly than the Eylea group. Specifically, in the HAWK and HARRIER trials, the Beovu group reached the target of ≥75% of patients achieving sustained dryness within 32 weeks and 20 weeks, respectively, whereas the Eylea group reached this target within 56 weeks and 52 weeks, respectively.
The results also showed that after a 3-month loading phase, the Beovu group achieved sustained retinal dryness with fewer injections compared to the Eylea group: in the HAWK and HARRIER trials, the mean number of injections required to achieve sustained dryness was 3.3 and 2.6 for Beovu, versus 5.4 and 4.4 for Eylea, respectively.
In wet AMD, effectively drying retinal fluid is a key treatment goal, and the volume of fluid in the retina determines the frequency of injections required.NovartisDirk Sauer, Head of Ophthalmology R&D, stated, “Frequent injections impose a significant burden on patients, leading to reduced treatment efficacy. This analysis further reinforces our confidence that Beovu is a highly effective option for rapid and sustained control of retinal fluid.”
Wet AMD (wet-AMD, image source: retinaboston.com)
Wet age-related macular degeneration (wet-AMD) is a leading cause of blindness, affecting more than 20 million people worldwide. Frequent intravitreal injections are a common reason for wet-AMD patients to discontinue treatment.
Beovu is a next-generation anti-vascular endothelial growth factor (VEGF) drug, approved in the United States in October 2019 and in the European Union in February 2020 for the treatment of wet AMD. In June this year, the U.S. labeling for Beovu was updated to include additional safety information regarding retinal vasculitis and retinal vascular occlusion.
Notably, Beovu is the first anti-VEGF agent demonstrating efficacy comparable to Eylea, while maintaining therapeutic efficacy with a 3-month dosing interval for maintenance therapy following a 3-month loading phase in eligible patients with wet age-related macular degeneration (wet AMD). By reducing the frequency of injections, Beovu improves patient treatment adherence, thereby effectively preserving visual acuity.
The active pharmaceutical ingredient of Beovu is brolucizumab (RTH258), a humanized single-chain antibody fragment (scFv) that targets all isoforms of vascular endothelial growth factor-A (VEGF-A). Single-chain antibody fragments have garnered significant attention in drug development due to their small size, enhanced tissue penetration, rapid systemic clearance, and favorable drug delivery properties.
Brolucizumab’s innovative structure gives it a small molecular weight of only 26 kDa, enabling potent inhibition of all VEGF-A isoforms with high affinity. In preclinical studies, brolucizumab inhibited the activation of VEGF receptors by blocking ligand-receptor interactions. Increased signaling through the VEGF pathway is associated with pathological ocular angiogenesis and retinal edema. In patients with chorioretinal vascular diseases, inhibition of the VEGF pathway suppresses the growth of neovascular lesions, alleviates retinal edema, and improves visual acuity. (Bioon.com)