Faricimab May Benefit Patients with DME Resistant to Aflibercept, Study Finds

Ryan B. Rush, MD

Credit: Southwest Retina

A switch to a faricimab treat-and-extend (TAE) protocol was associated with longer treatment intervals in aflibercept-resistant patients with diabetic macular edema (DME), according to new research.¹

The 1-year outcomes data showed a clinically significant minority of DME patients who switched to faricimab TAE were able to attain these improved intervals without comprising anatomical and/or visual outcomes.

“This study utilized a real-world TAE protocol typical to what most specialists who treat DME are familiar with, thereby allowing this study’s findings to be clinically meaningful to other physicians considering faricimab when aflibercept-recalcitrance is experienced,” wrote the investigative team, led by Ryan B. Rush, Southwest Retina Specialists.

The need for frequent treatment and insufficient response to treatment continue to affect patients with DME. Often, patients with DME experience persistent macular fluid on optical coherence tomography (OCT) despite monthly anti-vascular endothelial growth factor (VEGF) treatment. To target other mediators involved in macular leakage, faricimab, approved by the US Food and Drug Administration in January 2022, binds with high affinity to both VEGF-A and angiopoietin-2 (Ang-2).²

In this analysis, investigators assessed the 12-month outcomes of intravitreal faricimab in patients with treatment-resistant DME recalcitrant to intravitreal aflibercept, using a TAE protocol in a real-world setting. Previous findings from Rush and colleagues reported improvements in visual and anatomical outcomes with faricimab for a significant minority of treatment-resistant DME patients in a 4-month period.³

This study was performed as a retrospective interventional case series of patients with DME receiving care from February 2022 - June 2023. Patients at baseline had received ≥8 intravitreal aflibercept injections during the previous 12 months and had an OCT-measured central macular thickness of ≥320µm and identifiable edema. The baseline evaluation was indicated as the appointment where the change from intravitreal aflibercept to intravitreal faricimab was made.¹

For the analysis, the primary outcome was the percentage of patients who reached a treatment interval of ≥8 weeks and maintained a fluid-free macula on OCT at 12 months. A secondary outcome included the percentage of patients who improved ≥3 lines of Snellen visual acuity at 12 months.

A total of 51 eyes of 51 subjects were included in the analysis. Upon analysis, 39.2% (n = 20) of patients reached a treatment interval of ≥8 weeks and had a fluid-free macula on OCT at 12 months. The central macular thickness on OCT of the population showed a reduction from 400.2 µm at baseline to 340.6 µm at 12 months (P <.01).

Results from the analysis showed that 21.6% (n = 11) of patients improved ≥3 lines of Snellen visual acuity at 12 months. Overall, the study population’s visual acuity improved from 0.60 logMAR (Snellen 20/80) at baseline to 0.47 logMAR (Snellen 20/59) at 12 months (P <.01).

As long-term visual outcomes improve when all residual retinal edema is resolved, Rush noted a shorter delay before the switch to faricimab may have improved outcomes in the study population.

“Nevertheless, in the 40% of aflibercept-resistant DME patients who were able to extend to 8 weeks or beyond between faricimab treatments utilizing the TAE protocol employed in this study, all relevant parties benefit: the patient (less physician visits and treatments), the physician (more time to care for other patients requiring treatment), and society (lower cost burden on the insurance system,” he wrote.

References

1. Rush RB. One Year Results of Faricimab for Aflibercept-Resistant Diabetic Macular Edema. Clin Ophthalmol. 2023;17:2397-2403. Published 2023 Aug 16. doi:10.2147/OPTH.S424314
2. Kunzmann K. FDA approves Faricimab for patients with wet AMD or DME. HCP Live. April 15, 2022. Accessed September 6, 2023. https://www.hcplive.com/view/fda-approves-faricimab-patients-wet-amd-or-dme.
3. Rush RB, Rush SW. Faricimab for Treatment-Resistant Diabetic Macular Edema. Clin Ophthalmol. 2022;16:2797-2801