Real-world clinical and anatomical outcomes in patients with diabetic macular edema treated with faricimab: The FARETINA-DME study

Abstract

Purpose : Anti-vascular endothelial growth factor (VEGF) intravitreal agents for diabetic macular edema (DME) require frequent injections to mitigate vision loss. Faricimab is the only bispecific antibody for intraocular use that independently binds and neutralizes both angiopoietin-2 and VEGF-A. This study describes the largest real-world evaluation of injection frequency and clinical response of patients diagnosed with DME initiating faricimab.

Methods : FARETINA-DME is an ongoing, retrospective study using electronic health records (EHR) data derived from US ophthalmology clinics contributing to the American Academy of Ophthalmology IRIS^® Registry (Intelligent Research in Sight). Data analyzed identified patients diagnosed with DME who initiated faricimab treatment February 2022–June 2023. Patients with ≥12 months of EHR data prior to faricimab initiation, known laterality, ≥6 months of follow-up data, and ≥2 best-documented visual acuity (BDVA) measures were included.

Results : 5071 patients (7055 eyes) were treated with faricimab for DME, with a mean (standard deviation [SD]) of 5.8 (2.6) faricimab injections over a mean (SD) of 295.4 (87.6) days of follow-up. 53.2% of eyes had 20/40 or better BDVA at faricimab initiation. 851 (12.1%) eyes were anti-VEGF treatment naive. Mean (SD) injection frequency of anti-VEGFs in the prior 12 months was 5.7 (2.7) injections with a mean (SD) interval length of 51.2 (34.8) days. 72.1% of previously treated eyes were treated with aflibercept.
Mean (SD) change in BDVA from baseline after 4 faricimab injections was +4.3 (16.0) letters in treatment-naive eyes and +0.7 (11.0) letters in previously treated eyes. Among eyes with central subfield thickness (CST) data available (n=1181), mean (SD) CST improved after 6 months by –57.4 (40.6) µm in treatment-naive eyes and –34.7 (24.6) µm in previously treated eyes (nominal p<0.01). 1486 (21.1%) eyes had ≥12 months of follow-up, with 71.5% of these eyes extending their faricimab injection interval (>6 weeks interval) within 3 initial injections.

Conclusions : In FARETINA-DME, vision improvement (naive eyes) and stability (previously treated eyes) was observed, along with potential CST improvement. Faricimab treatment intervals were extended within 3 initial doses in most patient eyes. Extensions seen in interval dosing may correlate to early anatomical responses to faricimab in DME patients.

This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.