Faricimab reduces treatment burden of neovascular age-related macular degeneration: Lancet

A new study published in The Lancet suggests that Faricimab can effectively prolong the duration between treatments with continued efficacy and reduce treatment burden in patients with neovascular age-related macular degeneration (nAMD).

A bispecific antibody called faricimab works by simultaneously inhibiting angiopoietin-2 and vascular endothelial growth factor A. Jeffrey S. Heier and colleagues provide the initial findings of two phase 3 studies testing intravitreal faricimab for neovascular age-related macular degeneration, with extensions up to every 16 weeks.

Randomized, double-masked studies for TENAYA and LUCERNE were conducted at 271 locations around the globe. Based on protocol-defined disease activity evaluations at weeks 20 and 24, treatment-naive individuals with nAMD 50 years of age or older were randomly allocated to intravitreal faricimab 6 mg up to every 16 weeks or aflibercept 2 mg every 8 weeks. Patients, researchers, those who were evaluating the results, and the funders were all blinded to the group allocations. The primary endpoint of this study was the mean change in best-corrected visual acuity (BCVA) from baseline averaged across weeks 40, 44, and 48. Patients who had at least one dosage of trial therapy included in the safety analysis.

The key findings of this study were as follow:

1. Between February 19 and November 19, 2019 (TENAYA n=334 faricimab and n=337 aflibercept) and to March 11 and November 1, 2019 (LUCERNE n=331 faricimab and n=327 aflibercept), 1329 patients were randomly allocated between the two studies.

2. In both TENAYA and LUCERNE, the BCVA change from baseline with faricimab was non-inferior to aflibercept.

3. Faricimab and aflibercept both had similar rates of ocular side effects.

In conclusion, the key findings of this study suggest that patients with neovascular age-related macular degeneration who are both difficult to treat and treatment-naive are responding favorably to faricimab.

Reference:

Heier, J. S., Khanani, A. M., Quezada Ruiz, C., Basu, K., Ferrone, P. J., Brittain, C., Figueroa, M. S., Lin, H., Holz, F. G., Silverman, D., Abdulaeva, E., … Zeolite, C. (2022). 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 3, non-inferiority trials. In The Lancet (Vol. 399, Issue 10326, pp. 729–740). https://doi.org/10.1016/s0140-6736(22)00010-1