Personalized faricimab dosing shows durable efficacy in nAMD

A treat-and-extend personalized treatment with faricimab based on disease activity results in sustained gains in vision or anatomic outcomes through 2 years in patients with neovascular age-related macular degeneration (nAMD), reports a study. Moreover, nearly four in five (80 percent) patients have achieved extended dosing intervals of 12 weeks or more.

“The durability of treatment effect with faricimab in year 1 was extended further in year 2, with more faricimab-treated patients achieving and maintaining a Q16W (every 16 weeks) dosing regimen, and therefore receiving fewer injections of faricimab in year 2,” the researchers said.

Two phase III noninferiority trials (ie, TENAYA and LUCERNE) randomized treatment-naïve patients with nAMD aged ≥50 years to receive either intravitreal faricimab 6.0 mg Q16W or aflibercept 2.0 mg every 8 weeks (Q8W). Faricimab fixed dosing was based on protocol-defined disease activity at weeks 20 and 24 up to week 60, followed up to week 108 by a treat-and-extend personalized treatment interval regimen.

The researchers assessed efficacy through the change in best-corrected visual acuity (BCVA) from baseline at 2 years and the proportion of patients receiving Q16W, every 12 weeks (Q12W), and Q8W dosing at week 112 in the intention-to-treat population. For the safety analyses, they assessed ocular adverse events (AEs) in the study eye through week 112.

TENAYA and LUCERNE

Overall, 1,326 patients received treatment in TENAYA and LUCERNE. Of these, 1,113 (83.9 percent) completed treatment (faricimab: n=555; aflibercept: n=558). [Ophthalmology 2024;131:914-926]

In TENAYA, the BCVA change at 2 years was similar between faricimab (adjusted mean change [aMC], 3.7 letters, 95 percent confidence interval [CI], 2.1‒5.4) and aflibercept arms (aMC, 3.3 letters, 95 percent CI, 1.7‒4.9; mean difference [MD], 0.4 letters, 95 percent CI, ‒1.9 to 2.8).

The same was true for both treatment groups in LUCERNE (faricimab: aMC, 5.0 letters, 95 percent CI, 3.4‒6.6; aflibercept: aMC, 5.2 letters, 95 percent CI, 3.6‒6.8; MD, ‒0.2 letters, 95 percent CI, ‒2.4 to 2.1).

At week 112, 59.0 percent of patients in TENAYA and 66.9 percent in LUCERNE achieved Q16W faricimab dosing, increasing from year 1, while 74.1 percent and 81.2 percent achieved Q12W or longer dosing, respectively.

Ocular AEs in the study eye through week 112 did not significantly differ between faricimab and aflibercept arms in TENAYA (55.0 percent vs 56.5 percent) and LUCERNE (52.9 percent vs 47.5 percent).

“These data support dual angiopoietin-2 and VEGF-A inhibition with faricimab as a novel approach to target the angiopoietin–Tie2 and VEGF-A pathways involved in nAMD pathogenesis, leading to durable efficacy, giving physicians the potential to extend time between treatments without compromising vision or anatomic outcomes,” the researchers said.

Anti-VEGF therapy, the current standard of care for nAMD treatment, improves vision outcomes and prevents severe vision loss in many patients. However, long-term treatment outcomes in clinical practice are not as successful as those observed in clinical trials. [Eye (Lond) 2020;34:1966-1972]

“One likely explanation for this is undertreatment resulting from the treatment burden of frequent monitoring and intravitreal injections when using anti-VEGF therapy, particularly in an elderly population,” the researchers said.