Favourable opinion for reimbursement in the treatment of adult patients with reduced visual acuity due to macular oedema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).
Clinical Benefit
Substantial
The Committee deems that the clinical benefit of VABYSMO 120 mg/mL (faricimab) solution for injection is substantial in the MA indication.
Clinical Added Value
no clinical added value
Considering:
evidence of the non-inferiority of VABYSMO (faricimab) compared to EYLEA (aflibercept) for the mean change in best corrected visual acuity after 24 weeks of treatment, using a fixed treatment regimen of one injection every four weeks, in two phase 3, multicentre, randomised, double-masked studies, one in adult patients with macular oedema secondary to branch retinal vein occlusion (BRVO) and the other in adult patients with macular oedema secondary to central retinal vein occlusion or hemiretinal vein occlusion (CRVO/HRVO),
the short-term (24 weeks) safety profile of faricimab similar to that of aflibercept and similar to that observed in the other indications, marked, in particular, by ocular adverse events and adverse events related to the pharmacotherapeutic group (such as intraocular inflammation, retinal vasculitis or occlusive retinal vasculitis, and thromboembolic events, monitored in the context of the risk management plan),
but:
the lack of evidence of the superiority of VABYSMO (faricimab) compared to EYLEA (aflibercept) in terms of change in visual acuity after 24 weeks,
the absence of longer-term comparative efficacy and safety data demonstrating an advantage of VABYSMO (faricimab) compared to EYLEA (aflibercept), particularly in terms of reduction in the number of injections during the individualised treatment phase,
the Committee deems that VABYSMO (faricimab) solution for injection provides no clinical added value (CAV V) compared to EYLEA (aflibercept) in the treatment of adult patients with macular oedema secondary to BRVO or CRVO.
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