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Vabysmo (faricimab-svoa) - 3 indications
Scroll down for more information of each indication:
- for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration and Diabetic Macular Edema; approved January of 2022
- for the treatment of macular edema following retinal vein occlusion; approved October of 2023
General Information
Vabysmo (faricimab-svoa) is a vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) inhibitor.
Vabysmo is specifically indicated:
- for the treatment of patients with Neovascular (wet) Age-Related Macular Degeneration (nAMD)
- for the treatment of patients with Diabetic Macular Edema
- for the treatment of patients with macular edema following retinal vein occlusion
Vabysmo (faricimab-svoa) is supplied as a solution for intravitreal injection. Each vial should only be used for the treatment of a single eye. Scroll down for recommended dosing for each indication.
Mechanism of Action
Vabysmo (faricimab-svoa) is a humanized bispecific antibody that acts through inhibition of two pathways by binding to VEGF-A and Ang-2. By inhibiting VEGF-A, faricimab suppresses endothelial cell proliferation, neovascularization and vascular permeability. By inhibiting Ang-2, faricimab is thought to promote vascular stability and desensitize blood vessels to the effects of VEGF-A. Ang-2 levels are increased in some patients with nAMD and DME. The contribution of Ang-2 inhibition to the treatment effect and clinical response for nAMD and DME has yet to be established.
Side Effects
The most common adverse effect associated with the use of Vabysmo was conjunctival hemorrhage.
Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay, to permit prompt and appropriate management. Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection. There is a potential risk of arterial thromboembolic events (ATEs) associated with VEGF inhibition.
Indication 1 - for the treatment of Neovascular (Wet) Age-Related Macular Degeneration
TENAYA and LUCERNE were two identical, randomized, multicenter, double-masked, global studies evaluating the efficacy and safety of Vabysmo compared to aflibercept in 1,329 people living with wet age-related macular degeneration (671 in TENAYA and 658 in LUCERNE). Both studies met their primary endpoint, with Vabysmo given at intervals of up to every four months consistently shown to offer visual acuity gains that were non-inferior to aflibercept given every two months. In TENAYA and LUCERNE, the average vision gains from baseline at one year in the Vabysmo arms were +5.8 and +6.6 letters, respectively, compared to +5.1 and +6.6 letters in the aflibercept arms.
Indication 2 - for the treatment of Diabetic Macular Edema
YOSEMITE and RHINE are two identical, randomized, multicenter, double-masked, global studies evaluating the efficacy and safety of Vabysmo compared to aflibercept in 1,891 people with diabetic macular edema (940 in YOSEMITE and 951 in RHINE). Both studies met their primary endpoint, with Vabysmo at intervals of up to every four months consistently shown to offer visual acuity gains that were non-inferior to aflibercept given every two months. In YOSEMITE, the average vision gains from baseline at one year were +11.6 and +10.7 eye chart letters in the Vabysmo treat-and-extend and two-month arms, respectively, and +10.9 letters in the aflibercept arm. In RHINE, the average vision gains from baseline at one year were +10.8 and +11.8 letters in the Vabysmo treat-and-extend and two-month arms, respectively, and +10.3 letters in the aflibercept arm.
Indication 3 - for the treatment of macular edema following retinal vein occlusion
Approval Date: 2022-01-01
Company Name: Genentech/Roche