Practical implementation of a q4–q16 aflibercept treat-and-extend pathway for the treatment of neovascular age-related macular degeneration: Updated guidance from a UK expert panel

Abstract

Objectives This report, based on guidance from a panel of UK retina specialists, introduces a revised intravitreal aflibercept (IVT-AFL) treat-and-extend (T&E) pathway for the treatment of neovascular age-related macular degeneration (nAMD). The T&E pathway incorporates the updated IVT-AFL label (April 2021) allowing flexible treatment intervals of 4 weeks to 16 weeks, after three initiation doses and a further dose after 8 weeks. Practical guidance is provided on the clinical implementation of the revised pathway, with the aim of supporting clinical decision-making to benefit patients and addressing capacity issues in nAMD services. Methods Three structured round-table meetings of UK retina specialists were held online on 19 May, 16 June and 13 October 2021. These meetings were organised and funded by Bayer. Results The authors revised the previously published consensus pathway to reflect the changes to the IVT-AFL label and developed guidelines for the implementation of the pathway in UK clinical practice. The guidelines include topics such as recommendations for extending patients with 2- or 4-week adjustments, extending patients to 16-week treatment intervals, managing fellow eye involvement, and reducing treatment intervals for patients with particularly active disease. Conclusions The revised IVT-AFL T&E nAMD pathway offers guidance to clinicians seeking to increase the dosing flexibility of IVT-AFL, with 4- to 16-week treatment intervals, in line with the updated IVT-AFL label, to meet the continually evolving demands of nAMD service provision.

Dual pathway inhibition with faricimab for previously treated neovascular age-related macular degeneration and diabetic macular oedema: Guidance from a UK panel of retina specialists

“…Clinicians mostly treat nAMD using a exible T&E dosing regimen after an initial monthly treatment phase (i.e., loading) [7,29,33]. Treatment interval extension is considered appropriate when there is no retinal uid or other OCT biomarkers of active nAMD, with stable or better visual acuity or if visual acuity loss is not considered due to nAMD disease activity [33].…”

“…In post hoc exploratory evaluations of pivotal faricimab clinical trials in nAMD and DMO, ndings favour faricimab over a ibercept across multiple anatomic biomarkers for disease control, including absence of retinal uid, absence of DMO, resolution of macular leakage, secondary epiretinal membrane (ERM) formation, and resolution of retinal hyperre ective foci (HRF) [17,[19][20][21][22][23][24] (Table 2). Retinopathy Study (ETDRS) letters attributable to choroidal neovascularisation activity [29,30]. Fluorescein leakage or increase in lesion size on FFA may also indicate active disease [31].…”

Exploring Current Molecular Targets in the Treatment of Neovascular Age-Related Macular Degeneration toward the Perspective of Long-Term Agents

“…New neovascular AMD agents were developed to achieve longer and sustained disease control. With an extended regimen, treatment intervals can be extended up to 16 weeks in most cases using the available products, such as aflibercept, brolucizumab, and faricimab [81,[105][106][107][108]. Nevertheless, current efforts are concentrated on addressing the unmet needs stemming from anti-VEGF use.…”

Short-Term Real-World Outcomes of Intensive Aflibercept Injection for Refractory Neovascular Age-Related Macular Degeneration

“…As the discussion on the necessity of monthly aflibercept injections has emerged in patients with limited response to treatment for nAMD [ 7 , 8 , 9 ], in April 2021, the product license for aflibercept in Europe, used to treat patients with nAMD, was expanded to incorporate the option of dosing at 4-week intervals following the initial phase of three monthly doses and an additional dose after 8 weeks [ 10 ]. Since 2022, insurance coverage for aflibercept in South Korea has expanded to include the 4-week interval dosing regimen for patients requiring intensive treatment.…”