EYLEA (aflibercept) - Age-related macular degeneration (DMLA)

The Committee deems that the clinical benefit of EYLEA 114.3 mg/mL (aflibercept) solution for injection in vials is substantial only for the treatment of neovascular (wet) age-related macular degeneration (AMD) in adults.

Considering:

• the phase 3 PULSAR trial having compared aflibercept 8 mg every 12 weeks (Q12W) or every 16 weeks (Q16W) with a variable dosing regimen (after 3 monthly of injections) with aflibercept 2 mg every 8 weeks (Q8W) with a fixed dosing regimen (after 3 monthly injections) in adults with neovascular (wet) AMD, the results of which demonstrated:
  • the non-inferiority, without demonstration of a superiority, of the aflibercept 8 mg Q12W and 8 mg Q16W groups compared to the aflibercept 2 mg Q8W group in terms of change in best corrected visual acuity (BCVA, ETDRS) after 48 (primary endpoint) and 60 weeks (secondary endpoint) of treatment compared to baseline;
  • the superiority of aflibercept 8 mg Q12W + Q16W (grouped analysis) compared to aflibercept 2 mg Q8W on the percentage of patients with no intraretinal fluid (IRF) and no subretinal fluid (SRF) in the central subfield at week 16;
• a comparable tolerance between aflibercept 8 mg Q12W or Q16W and aflibercept 2 mg Q8W;
• the absence of demonstration of a superiority of aflibercept 8 mg Q12W or Q16W compared to aflibercept 2 mg Q8W in terms of quality of life;
• a simplified dosing regimen for EYLEA 114.3 mg/mL (aflibercept) compared to EYLEA 40 mg/mL (aflibercept) during the maintenance phase (interval of up to 5 months between two injections) but with no evidence of an additional impact on the organisation of care or the care or life pathway of patients compared to the other VEGF inhibitors used with a Treat & Extend regimen;

the Committee deems that EYLEA 114.3 mg/mL (aflibercept) solution for injection in vials provides no clinical added value (CAV V) compared to EYLEA 40 mg/mL (aflibercept) solution for injection in vials and pre-filled syringe.