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Faricimab Exhibits Durable Efficacy in nAMD Treatment in TENAYA and LUCERNE

The 48-week results suggest robust CST reduction and visual gains with faricimab up to every 16 week dosing, comparable with aflibercept ever 8-weeks.

New data indicate both vision gains and disease control in the TENAYA and LUCERNE studies were sustained in the maintenance phase in all faricimab dosing cohorts in patients with neovascular age-related macular degeneration (nAMD).

Faricimab was linked to improvement in best-corrected visual acuity (BCVA) of 45% of patients on every 16 week dosing (Q16W) and nearly 80% of patients on ≥Q12W dosing at Week 48, according to the findings.

“Robust visual and anatomical outcome improvements were achieved and maintained through week 48, regardless of treatment interval,” wrote study author Gemmy Cheung, MBBS, Singapore Eye Research Institute, Singapore National Eye Centre.

The research was presented in a poster at the American Academy of Ophthalmology 2022 Meeting in Chicago, Illinois.

The TENAYA and LUCERNE studies investigated the bispecific Ang2/vascular endothelial growth factor A (VEGF-A) inhibitor using an individualized treatment interval of up to every 16 weeks dosing (Q16W) in patients with nAMD.

After initial dosing and disease activity assessments at Weeks 20 and 24, patients were randomized 1:1 to faricimab 6.0 mg with fixed Q16W, Q12W, or Q8W intervals or aflibercept 2.0 mg with a q8w interval.

Disease activity criteria included an increase in central subfield thickness (CST) >50 μm compared with average CST over previous 2 scheduled visits or an increase in CST ≥75 μm compared with lowest CST recorded at either of 2 previously scheduled visits.

Or, disease activity was measured by a decrease of ≥5 letters of BCVA compared with average BCVA over previous 2 scheduled visits, due to nAMD or a decrease of ≥10 letters of BCVA compared with highest BCVA recorded over previous 2 scheduled visits, due to nAMD.

The baseline characteristics were considered generally well-balanced across treatment arms. At 1 year, TENAYA and LUCERNE met the primary endpoint, with 79% of patients receiving faricimab treatment achieving ≥Q12w dosing intervals at Week 48 and 45% of patients on Q16W dosing

The reductions in CST with faricimab up to Q16w were comparable with aflibercept Q8w and the effects of faricimab were durable, according to the findings. Regarding safety, faricimab was well-tolerated.There were low event rates of intraocular inflammation and reported in 2.0% and 1.2% of patients for faricimab and aflibercept, respectively.

Investigators noted no cases of retinal vasculitis or occlusive retinal vasculitis were reported.  They added that individuals who required faricimab Q8w dosing had generally worse baseline ocular characteristics versus extended treatment intervals.

Meaningful vision improvements were achieved and maintained through Week 48, regardless of faricimab treatment interval, according to the data. Additionally, meaningful anatomical improvements were achieved and maintained through Week 48, regardless of faricimab treatment interval.

Patients on Q16W dosing exhibited prolonged disease control with stabilized anatomic and vision outcomes.  While TENAYA and LUCERNE are two-year studies, The ongoing long-term extension study, AVONELLE-X, will generate 4-year long-term data.

The poster, “Faricimab in nAMD: 48-Week Results by Dosing Cohort in the TENAYA/LUCERNE Trials,” was presented at AAO 2022.