Roger A. Goldberg, MD: Faricimab Reduces Macular Leakage in Eyes with DME

Roger A. Goldberg, MD

Credit: ASRS

Treatment with faricimab (Vabysmo) resulted in a greater reduction in macular leakage in patients with diabetic macular edema (DME), with a larger proportion of patients achieving minimal to no leakage versus aflibercept, according to new research.

The post hoc analysis, presented at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in New Orleans, Louisiana, suggested the macular leakage area was more than 50% smaller in faricimab-treated eyes at 16 weeks and nearly twice as many faricimab-treated eyes (28.4%) showed resolution of leakage versus aflibercept (15.2%) at 16 weeks.

“It seems that faricimab is able to shift patients from a persistent leaky phenotype more likely into the resolution of macular leakage,” Roger A. Goldberg, MD, Bay Area Retina Associates told HCPLive at ARVO 2023. “We believe quite strongly that is driven by the angiopoietin-2 (ang-2) inhibition that faricimab offers.”

Blood vessel leakage in the macula is an important marker of vascular stability, often leading to more retinal fluid and increasing both swelling and blurry vision. The analysis of the YOSEMITE and RHINE trials evaluated if dual angiopoietin-2 (Ang-2)/vascular endothelial growth factor A (VEGF-A) inhibition with faricimab improved macular leakage over VEGF-A inhibition alone with aflibercept in patients with DME. The trials were identical, evaluating the efficacy and safety of 6.0-mg faricimab versus 2.0-mg aflibercept in patients with center-involving DME.

Individuals were randomized 1:1:1 to faricimab every 8 weeks (Q8W), faricimab according to a personalized treat-and-extend–based regimen, or aflibercept Q8W. Data were included from the first 16 weeks of the trial (matched-dosing phase) in which all patients received assigned study drug Q4W.

The analysis pooled the faricimab Q8W and treat-and-extend arms, receiving the same dosing regimen during this period. Outcomes for the analysis included macular leakage area and the proportion of patients with minimal to no macular leakage (0 – 1 mm²).

The pooled YOSEMITE and RHINE trials included 1216 patients in the pooled faricimab arm and 593 patients in the aflibercept arms. The analysis showed the median baseline macular leakage area was similar in the faricimab (24.58 mm2) and aflibercept arms (25.64 mm²).

At Week 16, data showed the median macular leakage area was significantly lower in the faricimab versus aflibercept arm (3.59 vs. 7.62 mm2, respectively; P <.0001). Moreover, a significantly greater proportion of patients receiving faricimab (28.4%) showed minimal to no leakage compared with those receiving aflibercept (15.2%) at 16 weeks (P <.0001).

For more insight into the analysis, watch the full interview with Goldberg at ARVO 2023 below.

Roger A. Goldberg, MD, reports having received consultant fees and financial support from Allergan, Apellis, Boehringer Ingelheim, Genentech, Regeneron, and others.

References

1. Goldberg RA, Kolomeyer A, Nudleman E, Csaky K, Willis J, Gibson K, Wang T, Haskova Z, Shildkrot, Amador M, Mar F. Faricimab reduces macular leakage vs aflibercept in patients with DME. Presented at the 2023 Association for Research in Vision and Ophthalmology Annual Meeting; April 2023; New Orleans, LA.