VABYSMO (faricimab) - Retrofoveal age-related macular degeneration, diabetic macular oedema, macular oedema secondary to branch retinal

Opinions on drugs - Posted on Mar 05 2025

First listing

Favourable opinion for reimbursement in:

neovascular (wet) retrofoveal age-related macular degeneration (nAMD);
the treatment of adult patients with visual impairment due to diabetic macular oedema (DME), in the event of diffuse forms or leakages close to the centre of the macula, in adults with a visual acuity of ≤ 5/10 and in whom diabetes management has been optimised;
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).

Unfavourable opinion for reimbursement in the other clinical situations for the indications relating to nAMD and visual impairment due to DME.

No clinical added value of the new form compared to the VABYSMO 120 mg/mL (faricimab) solution for injection in vial form already available.

Substantial	The Committee deems that the clinical benefit of VABYSMO (faricimab) 120 mg/mL solution for injection in pre-filled syringe is substantial in the treatment of neovascular (wet) retrofoveal age-related macular degeneration (nAMD) in adults.
Insufficient	The Committee deems that the clinical benefit of VABYSMO (faricimab) 120 mg/mL solution for injection in pre-filled syringe is insufficient in other cases to justify public funding in view of the available alternatives.