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The studies showed that treatment with Vabysmo resulted in early and sustained improvement in vision, meeting the primary endpoint of non-inferior visual acuity gains compared to treatment with aflibercept. Vabysmo also showed rapid and robust drying of retinal fluid from baseline, as measured by reduction in central subfield thickness. The safety profile of Vabysmo was consistent with previous trials. Results will be presented virtually on 11 February at Angiogenesis, Exudation and Degeneration 2023, organised by the
These encouraging results reinforce the potential of Vabysmo as a new treatment option for people experiencing vision loss associated with retinal vein occlusion,' said
Neovascular or 'wet' age-related macular degeneration (nAMD), diabetic macular edema (DME) and RVO together affect around 70 million people worldwide and are among the leading causes of vision loss.4-8 Data from the BALATON and COMINO studies will be submitted to health authorities around the world, including the
Retinal vein occlusion can cause fluid to become trapped within and under the retina, leading to rapid and severe vision loss if left untreated,' said
Vabysmo's efficacy and safety in nAMD and DME have been demonstrated by two-year data from four large, global studies involving more than 3,000 participants.10-13 Vabysmo is the first bispecific antibody approved for the eye with phase III studies supporting treatment intervals of up to four months for people with these conditions.14 It targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A).10,11 Globally, more than 450,000 Vabysmo doses have been distributed for treatment of these conditions to date.9
Study results3
In the BALATON and COMINO studies, patients were randomised 1:1 to receive six monthly injections of either Vabysmo (faricimab) (6.0 mg) or aflibercept (2.0 mg) for 20 weeks, with the primary endpoint measured at week 24. Both studies met their primary endpoint, with Vabysmo showing non-inferior visual acuity gains compared to aflibercept. The average vision gains from baseline were comparable between the two treatments in both studies. In BALATON, vision gains were +16.9 eye chart letters in the Vabysmo arm and +17.5 letters in the aflibercept arm at 24 weeks. In COMINO, vision gains were +16.9 letters in the Vabysmo arm and +17.3 letters in the aflibercept arm at 24 weeks. Additionally, the percentage of patients gaining 15 or more letters was comparable across treatment arms in both studies.
Fluid in the retina in the back of the eye, which may result from blood vessel leakage, can cause swelling and blurry vision.15 A secondary endpoint showed that Vabysmo achieved rapid and robust drying of retinal fluid from baseline, as measured by reduction in central subfield thickness (CST). In both studies, reductions in CST were comparable across treatment arms. In BALATON, CST reductions were -311.4 m in the Vabysmo arm and -304.4 m in the aflibercept arm. In COMINO, CST reductions were -461.6 m in the Vabysmo arm and -448.8 m in the aflibercept arm. Additionally, both studies showed that more Vabysmo patients had an absence of blood vessel leakage in the retina compared to aflibercept patients as seen in a pre-specified exploratory endpoint. In BALATON, one third of patients (34%) treated with Vabysmo had an absence of leakage compared to one fifth (21%) of aflibercept patients. In COMINO, the rates were 44% for Vabysmo patients versus 30% for aflibercept patients.
In both studies, Vabysmo's safety profile was consistent with previous trials. The most common adverse reaction was conjunctival haemorrhage (3%). Safety results were consistent across study arms.
The studies are ongoing, and data from weeks 24 to 72 will assess the potential of Vabysmo to extend dosing intervals up to every four months.
About the BALATON and COMINO studies
BALATON (NCT04740905) and COMINO (NCT04740931) are two randomised, multicentre, double-masked, global phase III studies evaluating the efficacy and safety of Vabysmo (faricimab) compared to aflibercept. For the first 20 weeks, patients are randomised 1:1 to receive six monthly injections of either Vabysmo (6.0 mg) or aflibercept (2.0 mg). From weeks 24-72, all patients receive Vabysmo (6.0 mg) up to every four months - according to a personalised treatment interval dosing regimen - using a treat-and-extend approach.
The BALATON study is being conducted in 553 people with branch retinal vein occlusion. The COMINO study is being conducted in 729 people with central retinal or hemiretinal vein occlusion.
The primary endpoint of each study is the change in best-corrected visual acuity from baseline at 24 weeks. Secondary endpoints include change in central subfield thickness and drying of retinal fluid from baseline over time up to 24 weeks.
About retinal vein occlusion (RVO)
RVO is the second most common cause of vision loss due to retinal vascular diseases.4 It affects an estimated 28 million adults globally, mainly those aged 60 or older, and can lead to severe and sudden vision loss.4,16 RVO typically results in sudden, painless vision loss in the affected eye because the vein blockage restricts normal blood flow in the affected retina, resulting in ischaemia, bleeding, fluid leakage and retinal swelling called macular edema.16-18 Currently, macular edema due to RVO is typically treated with repeated intravitreal injections of anti-vascular endothelial growth factor therapies.18 There are two main types of RVO: branch retinal vein occlusion, which affects more than 23 million people globally and occurs when one of the four smaller 'branches' of the main central retinal vein becomes blocked and central retinal vein occlusion, which is less common, affecting more than four million people worldwide, and occurs when the eye's central retinal vein becomes blocked.4,18
About the Vabysmo (faricimab) clinical development programme
About Vabysmo (faricimab)
Vabysmo is the first bispecific antibody approved for the eye.24,25 It targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A contribute to vision loss by destabilising blood vessels, causing new leaky blood vessels to form and increasing inflammation.10,11 By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilise blood vessels.10,11 Vabysmo is approved in more than 50 countries around the world, including
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Applying our extensive experience, we have already brought breakthrough ophthalmic treatments to people living with vision loss. Susvimo (previously called Port Delivery System with ranibizumab) 100 mg/mL for intravitreal use via ocular implant is the first
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