Faricimab Supports Dose Interval Extension in Treatment-Naïve Patients with nAMD

Recent post-hoc analyses of the TENAYA/LUCERNE trials have highlighted a variety of factors associated with the extended durability of faricimab in treating patients with neovascular age-related macular degeneration (nAMD), supporting that early fluid resolution with faricimab contributes to extended durability and improved outcomes.1

Presented at the 43rd Annual Scientific Meeting of the American Society of Retina Specialists in Long Beach, CA, by Benjamin Bakall, MD, PhD, Associated Retina Consultants, these analyses examined the pooled data from TENAYA/LUCERNE, investigating baseline and early treatment response variables associated with extended dosing in treatment-naïve patients with nAMD.1

The original TENAYA/LUCERNE trials were identically designed randomized, double-masked, active comparator-controlled phase 3 trials, conducted across 271 clinical sites globally. A total of 989 patients were included and randomized 1:1 to either faricimab 6mg up to Q16W after 4 initial doses every 4 weeks or aflibercept 2mg Q8W after 3 initial doses given every 4 weeks. After initial dosing, the faricimab arm was divided into Q16W, Q12W, and Q8W treatment patterns through week 60.2

Investigators from TENAYA and LUCERNE observed comparable improvements in best-corrected visual acuity (BCVA) between both cohorts; however, patients treated with faricimab achieved longer dose interval extension, proving the medication’s noninferiority to aflibercept. The 1- and 2-year findings both arrived at this conclusion.2

Bakall and colleagues conducted univariate analyses of these trials, examining the association between baseline and early treatment response variables and always extended dosing (≥ Q12W) from week 20-24 through to week 112. Additionally, univariate followed by multivariable analyses were conducted to examine the association between baseline and early treatment response variables and patient eligibility for potential Q20W extension during the T&E phase.1

Investigators found that, when compared with patients given ≥1 Q8W to week 112 (n = 248), patients always on extended dosing (n = 310) exhibited lower baseline central subfield thickness (CST) (345 µm versus 374 µm; P = .006), lower baseline pigment epithelial detachment (PED) thickness (215 µm versus 315 µm; P <.0001), and more fibrovascular PEDs at baseline (85% versus 73%; P = .0008).1

Bakall and colleagues reported the odds ratios for potential Q20W extension during the T&E phase (n = 591), which increased with baseline presence of intraretinal fluid (OR 1.5; 95% CI, 1.1-2.1), lower maximum PED thickness at baseline (OR 1.3; 95% CI, 1.2-1.5), and absence of subretinal fluid at week 12 (OR 2.4; 95% CI, 1.4-4.1). The team noted these particular data as possible reference points for potential treatment extension in clinical practice.1

“These…post-hoc analyses provide further insights into factors associated with the extended durability of the dual angiopoietin-2/vascular endothelial growth factor-A inhibitor, faricimab, in treatment-naïve patients with nAMD, and support that early fluid resolution with faricimab contributes to extended durability and improved outcomes,” Bakall and colleagues wrote.1

References

1. Bakall B. Baseline and Early Treatment Response Variables Associated With Faricimab Durability in Treatment-Naïve nAMD: TENAYA/LUCERNE Post-Hoc Analyses. Abstract presented at the 43rd Annual Scientific Meeting of the American Society of Retina Specialists in Long Beach, CA, July 30-August 2, 2025.

2. Khanani AM, Kotecha A, Chang A, et al. TENAYA and LUCERNE: Two-Year Results from the Phase 3 Neovascular Age-Related Macular Degeneration Trials of Faricimab with Treat-and-Extend Dosing in Year 2. Ophthalmology. 2024;131(8):914-926. doi:10.1016/j.ophtha.2024.02.014