Faricimab Effective for nAMD Eyes with Prior Anti-VEGF Treatment, Study Finds

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A single intravitreal injection of faricimab was associated with favorable efficacy and safety in patients with neovascular age-related macular degeneration (nAMD) with a prior anti-vascular endothelial growth factor (VEGF) treatment history.¹

The analysis revealed no significant change in central subfield thickness (CST) or best-corrected visual acuity (BCVA) after switching from intravitreal aflibercept or brolucizumab, but a significant decrease in central choroidal thickness (CCT) may indicate a positive response to faricimab.

“These findings suggest that intravitreal faricimab is generally safe and effective in terms of improving the choroidal vascular circulation,” wrote the investigative team, led by Hidenori Takahashi, MD, PhD, MD, PhD, from the department of ophthalmology at Jichi Medical University.

A bispecific antibody targeting both VEGF and angiopoietin-2 (Ang-2), faricimab was approved by the US Food and Drug Administration (FDA) in January 2022, based on the pivotal phase 3 TENAYA and LUCERNE trials.² Trial results showed patients with treatment-naive nAMD who received faricimab treatment achieved non-inferior BCVA to those treated with aflibercept, even with longer treatment intervals.

However, the study team indicated challenges in applying the results to a broader population, particularly in Japan.¹ By focusing on patients with treatment-naive AMD, the applications to previously treated patients were limited, and the trials also lacked a comparison to intravitreal brolucizumab. There is also limited evidence on the efficacy and safety of switching treatments for retinal diseases.

Reports from Japan suggest the efficacy of brolucizumab is superior to aflibercept in the treatment of sub-retinal pigment epithelium lesions and in reducing choroidal thickness. As a result, the study team noted the importance of analyzing faricimab in those in Japan with prior anti-VEGF history, who often have a higher prevalence of polypoidal choroidal vasculopathy and pachychoroid, and of conducting separate analyses for the various anti-VEGF agents used.

This real-world study analyzed the short-term safety and efficacy of intravitreal faricimab for nAMD in patients in Japan with a prior treatment history. A total of 80 eyes of 75 patients with nAMD previously treated with aflibercept or brolucizumab were enrolled in the study. Each patient received the first faricimab injection between May 2022 and September 2022.

Patients were instructed to maintain their regular visit intervals (± 1 week) after the initial faricimab injection, regardless of the presence or absence of exudative changes on that day. The primary outcome measures were BCVA, CST, and CCT compared before the initial faricimab injection and after the treatment interval matching the previous duration. Potential adverse events were measured in the safety outcome evaluation.

Baseline characteristics were considered comparable between aflibercept and brolucizumab before switching, aside from the injection interval, which was longer in the brolucizumab group (10.9 ± 3.5 vs. 8.8 ± 3.6 weeks; P = .015).

Upon analysis, investigators found CCT decreased significantly after the switch (P <.0001), but no significant change in CST (P = .99) or BCVA (P = .29). Data showed the mean BCVA changed from 0.34 ± 0.37 to 0.36 ± 0.40, CST changed from 242 ± 72 to 242 ± 82 µm, and CCT changed from 189 ± 98 to 179 ± 97 µm.

The analysis reported CCT decreased by 8.7 ± 2.5 µm (P <.0001) in eyes previously treated with brolucizumab and by 13.1 ± 3.6 µm (P <.0001) in eyes previously treated with aflibercept. Investigators indicated the differences in the CCT decrease in the brolucizumab and aflibercept groups were not statistically significant (P = .32). No adverse events were identified throughout the study period.

In their conclusion, Takahashi and colleagues noted the intriguing nature of the accumulating evidence on the relationship between pachychoroid and angiopoietins, particularly in an Asian population.

“Taken together, our results support the hypothesis that dual Ang-2/VEGF-A inhibition potentiates choroidal vascular remodeling, which might give better results for Asian patients with nAMD, especially those associated with the pachychoroid phenotype,” investigators wrote.

References

1. Inoda S, Takahashi H, Takahashi R, et al. Visual and Anatomical Outcomes After Initial Intravitreal Faricimab Injection for Neovascular Age-Related Macular Degeneration in Patients with Prior Treatment History. Ophthalmol Ther. 2023;12(5):2703-2712. doi:10.1007/s40123-023-00779-w
2. Kunzmann K. FDA approves Faricimab for patients with wet AMD or DME. HCP Live. April 15, 2022. Accessed September 14, 2023. https://www.hcplive.com/view/fda-approves-faricimab-patients-wet-amd-or-dme.