Importance In the TENAYA and LUCERNE randomized clinical trials (RCTs), approximately 80% of study participants with treatment-naive neovascular age-related macular degeneration (nAMD) achieved at least every-12-week faricimab dosing at week 112. Subsequent post hoc analyses showed more rapid drying with faricimab compared with aflibercept, 2 mg, during the initial head-to-head dosing phase (weeks 0-12). Objective To investigate whether rapid drying with faricimab, specifically intraretinal fluid (IRF) and subretinal fluid (SRF) resolution through week 12, is associated with later treatment durability. Design, Setting, and Participants This is a post hoc analysis of faricimab-treated study participants from the TENAYA and LUCERNE RCTs, which were randomized, double-masked, multicenter, noninferiority studies of the efficacy and safety of faricimab, 6 mg, up to every 16 weeks vs aflibercept, 2 mg, every 8 weeks. Study participants in this post hoc analysis were those who had treatment-naive nAMD and were in the faricimab arm of TENAYA and LUCERNE. Data analysis was performed from July 2024 to December 2025. Intervention Faricimab, 6 mg, up to every 16 weeks after 4 loading doses (received once every 4 weeks). Following disease activity assessments at week 20 or 24, participants received fixed dosing up to every 16 weeks until week 60 and then a treat-and-extend–based dosing regimen. Main Outcomes and Measures Multinomial logistic regression modeling was used to test the association between resolution of IRF and SRF through week 12 and the faricimab treatment interval at week 20 or 24 (the first opportunity to extend treatment intervals) and at week 112 (study completion). Results This analysis included 552 participants with their dosing interval at week 20 or 24 available (265 participants with IRF and SRF resolution and 287 without resolution); among them, 478 patients had their dosing interval at 112 weeks available (223 participants with IRF and SRF resolution and 255 without resolution). Study participants with IRF and SRF resolution through week 12, compared with those without resolution through week 12, were more likely to receive every-16-week dosing than every-8-week dosing (odds ratio OR, 1.99; 95% CI, 1.23-3.21; P = .005) and to receive every-12-week dosing than every-8-week dosing (OR, 1.77; 95% CI, 1.09-2.87; P = .02) at week 20 or 24, and they were more likely to receive every-16-week dosing than every-8-week dosing at week 112 (OR, 1.76; 95% CI, 1.10-2.83; P = .02). Conclusions and Relevance These findings suggest that rapid fluid resolution through week 12 with faricimab may be a predictor of extended durability (dosing intervals of every 12 weeks or longer) in participants with nAMD. Trial Registration ClinicalTrials.gov Identifiers: NCT03823287 and NCT03823300
Pitcher et al. (Thu,) studied this question.