The following is a summary of “Two-Year Results from the Phase 3 Neovascular Age-Related Macular Degeneration Trials of Faricimab with Treat-and-Extend Dosing in Year 2,” published in the February 2024 issue of Ophthalmology by Khanani et al. 

Researchers conducted a prospective study assessing the effectiveness, longevity, and safety of the bispecific antibody faricimab over two years, targeting both angiopoietin-2 and VEGF-A for inhibition.

They enrolled treatment-naive patients aged 50 or older with neovascular age-related macular degeneration (nAMD). Patients were randomly assigned to receive either faricimab 6.0 mg every 16 weeks (Q16W) or aflibercept 2.0 mg every 8 weeks (Q8W). Faricimab dosing was adjusted based on protocol-defined disease activity from week 20 to 24 up to week 60, followed by personalized treatment extended regimens up to week 108. The primary outcome was BCVA from baseline, averaged over weeks 104, 108, and 112, and the proportion of patients receiving Q16W, every Q12W, and Q8W dosing at week 112. 

The results showed that TENAYA/LUCERNE (1,326 patients): 83.9% completed treatment (555 faricimab; 558 aflibercept). BCVA change at 2 years: TENAYA (+3.7 letters [95% CI: +2.1 to +5.4] vs. +3.3 letters [95% CI: +1.7 to +4.9]; mean difference: +0.4 letters [95% CI: -1.9 to +2.8]) and LUCERNE (+5.0 letters [95% CI: +3.4 to +6.6] vs. +5.2 letters [95% CI: +3.6 to +6.8]; mean difference: -0.2 letters [95% CI: -2.4 to +2.1]). Week 112: TENAYA (59.0% Q16W faricimab; 74.1% Q12W or longer dosing) and LUCERNE (66.9% Q16W faricimab; 81.2% Q12W or longer dosing). Ocular AEs: TENAYA (faricimab 55.0%, aflibercept 56.5%) and LUCERNE (faricimab 52.9%, aflibercept 47.5%) through week 112.

Investigators concluded that using a treat-and-extend approach with faricimab for nAMD effectively preserved vision gains over two years, allowing most patients to benefit from longer treatment intervals.

Source: aaojournal.org/article/S0161-6420(24)00134-9/fulltext#%20