*Vabysmo sustained robust drying of retinal fluid, often associated with distorted or blurry vision
*Up to 60% of people receiving Vabysmo were able to extend treatment intervals to three or four months apart
*Detailed results from two global Phase III RVO studies will be presented at Angiogenesis, Exudation, and Degeneration 2024
*Vabysmo is approved in the US for RVO, and in more than 90 countries around the world for people living with nAMD and DME
"This is the first time that vision and anatomical improvements have been maintained for more than a year in global Phase III studies for both branch and central retinal vein occlusion," said
Results will be presented virtually on
"The sustained vision improvements and retinal drying seen up to 72 weeks reaffirm Vabysmo as an effective treatment for retinal vein occlusion," said
Both studies evaluated the average change in best-corrected visual acuity (BCVA) score (the best distance vision a person can achieve - including with correction such as glasses - when reading letters on an eye chart) from baseline. The studies also tracked the amount of swelling in the back of the eye due to retinal fluid, as measured by central subfield thickness (CST). Reductions in CST indicate improvement. Overall, results showed the vision improvements and reductions in retinal fluid achieved in the first 24 weeks of the studies were maintained up to 72 weeks.
Results for BRVO (BALATON)1:
*Vision gains: At 72 weeks, people receiving Vabysmo as a first-line treatment gained 18.1 letters on the eye chart, while people switched from aflibercept to Vabysmo gained 18.8 letters. During the first 24 weeks, vision gains were +16.8 eye chart letters in people receiving Vabysmo and +17.5 letters in people receiving aflibercept.
*Retinal drying: At 72 weeks, people receiving Vabysmo as a first-line treatment saw a 310.9 µm reduction in retinal swelling, as measured by CST, while those switched from aflibercept to Vabysmo saw a reduction in CST of 307 µm. During the first 24 weeks of the study, CST reductions were 314.5 µm in people receiving Vabysmo and 307.6 µm in people receiving aflibercept.
Results for CRVO (COMINO)2:
*Vision gains: People receiving Vabysmo as a first-line treatment gained 16.9 eye chart letters at 72 weeks, while people switched from aflibercept to Vabysmo gained 17.1 eye chart letters. During the first 24 weeks of the study, vision gains were +16.9 eye chart letters in people receiving Vabysmo and +17.3 letters in people receiving aflibercept.
*Retinal drying: People receiving Vabysmo as a first-line treatment saw a 465.9 µm reduction in retinal swelling, as measured by CST, while those switched from aflibercept to Vabysmo saw a reduction in CST of 460.6 µm at 72 weeks. During the first 24 weeks of the study, reductions in CST were 462.3 µm in people receiving Vabysmo and 447.8 µm in people receiving aflibercept.
Vabysmo is the first and only bispecific antibody approved for the eye, uniquely engineered to target and inhibit two signalling pathways, which are linked to a number of vision-threatening retinal conditions, by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) to restore vascular stability.6-9
To date, Vabysmo is approved in more than 90 countries around the world for people living with neovascular or 'wet' age-related macular degeneration (nAMD) and diabetic macular edema (DME), with public reimbursement in over 25 markets and more than 2.5 million doses distributed globally.10
In
About the BALATON and COMINO studies1,2
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, people were randomised 1:1 to receive monthly injections for six months of either Vabysmo (6.0 mg) or aflibercept (2.0 mg). From weeks 24 to 72, all individuals received Vabysmo (6.0 mg) up to every four months, using a treat-and-extend dosing regimen.
The BALATON study was conducted in 553 people with branch retinal vein occlusion. The COMINO study was conducted in 729 people with central retinal or hemiretinal vein occlusion. The primary endpoint of each study was change in best-corrected visual acuity (BCVA) from baseline at 24 weeks. Secondary endpoints for weeks 0-24 of the studies included change in central subfield thickness (CST) and drying of retinal fluid, from baseline over time up to week 24. Secondary endpoints for weeks 24-72 of the studies assessed change in BCVA from baseline, change in CST from baseline and the proportion of individuals on treat-and-extend intervals.
About retinal vein occlusion (RVO)
RVO is the second most common cause of vision loss due to retinal vascular conditions. It affects an estimated 28 million adults globally, mainly those aged 60 or older, and can lead to severe and sudden vision loss.11,12 The level of angiopoietin-2 (Ang-2) is elevated in RVO and it is thought that increased Ang-2 expression drives disease progression, alongside vascular endothelial growth factors (VEGF).13,14 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 bleeding, fluid leakage and retinal swelling called macular edema.12,15,16 Currently, macular edema due to RVO is typically treated with repeated intravitreal injections of anti-VEGF therapies.15 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, affecting more than four million people worldwide, and occurs when the eye's central retinal vein becomes blocked.11,16
About the Vabysmo® (faricimab) clinical development programme
About Vabysmo® (faricimab)
Vabysmo is the first bispecific antibody approved for the eye.6,7 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. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilise blood vessels.8,9 Vabysmo is approved in more than 90 countries around the world, including
About
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Applying our extensive experience, we have already brought breakthrough ophthalmic treatments to people living with vision loss. Susvimo(TM) (previously called Port Delivery System with ranibizumab) 100 mg/mL for intravitreal use via ocular implant is the first
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References
[1] Clinical Trials.gov. A study to evaluate the efficacy and safety of faricimab in participants with macular edema secondary to branch retinal vein occlusion (BALATON) [Internet; cited
[2] Clinical Trials.gov. A study to evaluate the efficacy and safety of faricimab in participants with macular edema secondary to central retinal or hemiretinal vein occlusion (COMINO) [Internet; cited
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[7] MHRA approves faricimab through international work-sharing initiative [Internet; cited
[8] Heier JS, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase III, non-inferiority trials.
[9] Wykoff C, et al. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with DME (YOSEMITE and RHINE): two randomised, double-masked, phase III trials.
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[11] Song P, et al. Global epidemiology of retinal vein occlusion: a systematic review and meta-analysis of prevalence, incidence, and risk factors.
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[13] Joussen et al. Angiopoietin/Tie2 signalling and its role in retinal and choroidal vascular diseases: a review of preclinical data. Eye. 2021;35:1305-1316.
[14] Regula JT, et al. Targeting key angiogenic pathways with a bispecific CrossMab optimized for neovascular eye diseases. EMBO Molecular Medicine. 2016;8:1265-88.
[15] Schmidt-Erfurth U, et al. Guidelines for the Management of Retinal Vein Occlusion by the
[16] Campochiaro P. Molecular pathogenesis of retinal and choroidal vascular diseases. Prog
[17] Clinical Trials.gov. A study to evaluate the long-term safety and tolerability of Vabysmo in participants with nAMD (AVONELLE-X) [Internet; cited
[18] Clinical Trials.gov. A study to evaluate the long-term safety and tolerability of Vabysmo in participants with DME (Rhone-X) [Internet; cited
[19] Clinical Trials.gov. A study to investigate faricimab treatment response in treatment-naïve, underrepresented patients with DME (ELEVATUM). [Internet; cited
[20] APVRS. Design and Rationale of the SALWEEN Trial: A Phase 3b/4 Study of Faricimab, a Dual Angiopoietin-2 and Vascular Endothelial Growth Factor-A Inhibitor, in Patients With Polypoidal Choroidal Vasculopathy. [Internet; cited
[21] Clinical Trials.gov. A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products (VOYAGER). [Internet; cited
[22] Chugai obtains regulatory approval for Vabysmo, the first bispecific antibody in ophthalmology, for neovascular age-related macular degeneration and diabetic macular edema [Internet; cited
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[24]
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