Switch to Faricimab Improves Short-Term Anatomical Outcomes in DME

A switch to faricimab led to a notable reduction in central retinal thickness (CRT) and volume (CRV), in patients with diabetic macular edema (DME), while best-corrected visual acuity (BCVA) did not exhibit a significant functional improvement.¹

This retrospective chart review evaluated real-world data in patients with DME treated with intravitreal faricimab, who demonstrated an insufficient response to prior anti-vascular endothelial growth factor (VEGF) therapy.

“With our study, we showed immediate and significant improvements of structural measures, as reductions of CRT and CRV were observed, while an improvement of the visual acuity was not noted in the follow-up exam, following a therapy switch to faricimab,” wrote the investigative team, led by Peter Wolfrum, MD, department of ophthalmology, University Medical Center, Johannes Gutenberg-University Mainz.

Although a first-line option for DME, some individuals with DME experience insufficient treatment response to anti-VEGF therapy, which may necessitate a switch to a different anti-VEGF agent.² Faricimab, a novel bispecific antibody-based therapy, was approved by the US Food and Drug Administration (FDA) in January 2022, addressing VEGF-A and angiopoietin 2 (Ang-2).³

Real-world settings typically demonstrate inferior outcomes to controlled clinical trial settings, indicating the importance of real-world data. In this study, Wolfrum and colleagues sought to evaluate short-term clinical outcomes and the influencing factors of an anti-VEGF switch to faricimab in patients with DME in an ophthalmological department.¹

All patients who received prior anti-VEGF therapy and switched to faricimab between October 2022 and January 2024 were considered for inclusion (n = 33). Insufficient response was typically defined as a lack of reduction in CRT and visual acuity deterioration using the prior anti-VEGF agent.

Investigators obtained data from each patient at baseline, including demographics, medical history, BCVA, CRT, and CRV. For the analysis, the primary outcomes were the changes in structural and functional measures at the 4-week follow-up visit after the last faricimab injection, compared with baseline.

The team also conducted a subgroup analysis to assess differences in patient baseline characteristics between faricimab responders and reduced-responders. Influencing factors on the follow-up BCVA and CRT were additionally measured in the analysis.

Overall, 25 eyes from 16 patients met the inclusion criteria. Of the population, 3 female and 13 male patients, the mean age was 65 years and patients received an initial anti-VEGF injection approximately 4.6 years before switching to faricimab.

After the switch to faricimab, patients exhibited no significant improvement in BCVA. The Early Treatment Diabetic Retinopathy Study (ETDRS) letters rose from 59.4 ± 13.4 letters at baseline to 61.4 ± 12.8 letters at follow-up (P =.26).

On the other hand, the CRT was significantly reduced from 414.4 ± 126.3 µm at baseline to 353.3 ± 131.1 µm during follow-up (P <.011). The 3 mm CRV also demonstrated a significant reduction, from 2.8 ± 0.5 mm3 at baseline to 2.6 ± 0.6 mm3 at follow-up (P <.012).

For inclusion in the subgroup analysis, 7 patients met the responder criteria. Those in the responder group had an average baseline ETDRS score of 52.9 ± 18.5 letters, with a mean gain of 10 ± 7.6 letters at the follow-up. Responders also demonstrated a mean CRT of 464.6 ± 113.1 µm, with an average reduction of –194.4 ± 99.3 µm.

Upon further analysis, Wolfrum and colleagues found higher baseline BCVA was linked to better follow-up ETDRS scores (P <.001). A higher baseline CRT (P <.003), number of prior anti-VEGF agents (P <.034), and prior corticosteroid injections (P <.019) were also linked to an improved follow-up CRT.

“Even though a functional improvement was not observed, faricimab proved to be safe and demonstrated stable visual acuity as well as effective anatomical improvements in the short-term,” they wrote. “Long-term data are necessary to evaluate, especially further changes of the visual function.”

References

1. _{Wolfrum P, Böhm EW, Lorenz K, Stoffelns B, Pfeiffer N, Korb CA. Short-Term Clinical Outcomes of Patients with Diabetic Macular Edema Following a Therapy Switch to Faricimab. J Clin Med. 2024;13(15):4508. Published 2024 Aug 1. doi:10.3390/jcm13154508}
2. _{Hussain RM, Ciulla TA. Treatment strategies for refractory diabetic macular edema: switching anti-VEGF treatments, adopting corticosteroid-based treatments, and combination therapy. Expert Opin Biol Ther. 2016;16(3):365-374. doi:10.1517/14712598.2016.1131265}
3. _{Kunzmann K. FDA Approves Faricimab for Patients with Wet AMD or DME. Published January 28, 2022. Accessed August 28, 2024. https://www.hcplive.com/view/fda-approves-faricimab-patients-wet-amd-or-dme}