(172) Two-year real-world clinical outcomes in patients with diabetic macular edema treated with faricimab in the US: The FARETINA-DME study

Background: : Limited real-world evidence on patients with DME, their treatment patterns, and clinical outcomes with novel therapeutic agents.

Objective: : Describe outcomes in DME patients treated with faricimab (FAR) who were either treatment naive or previously treated with another anti-vascular endothelial growth factor (aVEGF) agent.

Methods: : FARETINA-DME is a retrospective study using electronic health record (EHR) data from US ophthalmology practices contributing to the American Academy of Ophthalmology IRIS Registry (Intelligent Research in Sight). Patients with DME who initiated FAR treatment between Feb-Sep 2022, had ≥ 12 months of EHR data prior to FAR initiation, and known laterality were considered in the initial cohort. Patients with ≥ 24 months of follow-up, and ≥ 2 best corrected visual acuity (BCVA) measures were included in the analyses.

Results: : 953 patients (1,254 eyes) with DME had 2 years of treatment with FAR. 157 eyes were aVEGF treatment naïve. Among the 838 patients (1,097 eyes) who were previously treated, 601 eyes were treated with aflibercept 2mg (AFL) and 54 eyes were treated with bevacizumab (BEV) prior. The AFL prior cohort injection intervals increased by 12 days through FAR injection 8, while the BEV prior cohort intervals increased by 11 days through FAR injection 8. VA remained stable in both cohorts. In treatment-naïve eyes, mean (standard deviation [SD]) VA at baseline was 60.4 (19.8) letters and improved to 63.1 (21.6) letters at 24 month follow up. In previously treated eyes, mean (SD) VA at baseline was 65.0 (17.5) letters and remained stable at 64.4 (20.1) letters at 24 month follow up. A decreasing trend in mean (SD) number of FAR injections in the first vs second half of year one was noted (4.1 (1.4) vs 2.1 (1.8) for treatment-naïve eyes and 4.1 (1.3) vs 2.8 (1.6) for previously treated eyes). Further decrease was noted in the first vs second half of year two (1.8 (1.7) vs 1.6 (1.6) for treatment-naïve eyes and 2.3 (1.5) vs 2.2 (1.6) and for previously treated eyes). Safety profile of FAR was consistent with the overall safety of the phase III clinical trials.

Conclusions: : In this real-world study of 2 years FAR treatment, vision improved in treatment-naïve eyes and remained stable in previously treated eyes. Eyes that were previously treated with AFL or BEV were able to extend further following FAR initiation. There were fewer FAR injections observed in year 2, suggesting further treatment interval extension and decreased injection burden for patients. These findings support the real-world effectiveness, safety and durability of FAR for treatment of DME.

Sponsorship:: Genentech, Inc