A retrospective study from Juntendo University Hospital has provided real-world evidence supporting the clinical effectiveness of faricimab for treating diabetic macular edema (DME), demonstrating significant anatomical improvements and visual benefits in treatment-naïve patients.
The study, published in PLOS ONE, analyzed outcomes from 18 patients (22 eyes) treated with intravitreal faricimab between July 2022 and July 2023. Researchers divided participants into treatment-naïve patients (12 patients, 15 eyes) and those switched from other anti-VEGF therapies (6 patients, 7 eyes).
Significant Anatomical Improvements Across Patient Groups
Central macular thickness (CMT) showed substantial improvement in both patient cohorts. Treatment-naïve patients experienced a reduction from 507 ± 185 μm at baseline to 359 ± 153 μm at endpoint (p=0.002). Patients switched from other treatments saw their CMT decrease from 414 ± 158 μm to 341 ± 148 μm (p=0.04).
"The CMT significantly improved after IVF from the baseline for all cases, naïve and switched groups," wrote lead author Toshiaki Hirakata, MD, PhD, from the department of ophthalmology at Juntendo University Faculty of Medicine.
The percentage of patients achieving CMT under 300 μm increased significantly in both groups following faricimab treatment, indicating effective fluid control and anatomical restoration.
Visual Acuity Benefits Primarily in Treatment-Naïve Patients
Visual outcomes varied between patient groups. Treatment-naïve patients demonstrated significant improvement in best-corrected visual acuity, with logMAR BCVA improving from 0.24 ± 0.31 to 0.16 ± 0.26 (p=0.03). However, patients switched from other anti-VEGF therapies showed no significant change in visual acuity (p=0.31), though they maintained stable vision while achieving anatomical improvements.
The differential visual response may reflect the advanced disease state in switched patients, who had received an average of 7.6 ± 9.2 previous anti-VEGF injections before transitioning to faricimab.
Flexible Dosing Regimens Prove Effective
Unlike the structured protocols of the pivotal YOSEMITE and RHINE trials, this real-world study employed flexible dosing strategies. Patients received treatment under either pro re nata (PRN) or treat-and-extend (TAE) regimens, with many not receiving formal loading phases.
Of the 15 PRN cases, only 3 received the standard 3 monthly loading injections, while 12 began treatment without an induction period. Similarly, among 7 TAE cases, 5 received loading injections and 2 did not. Despite this variability, patients achieved meaningful clinical outcomes with an average of 3.3 ± 1.9 injections over 6.3 ± 3.6 months of follow-up.
Safety Profile Remains Favorable
No significant ocular or systemic adverse events occurred during the study period. Intraocular pressure remained within normal ranges throughout treatment, consistent with faricimab's established safety profile from clinical trials.
Clinical Context and Implications
Diabetic retinopathy represents the most common microvascular complication in diabetes patients, with DME being a leading cause of vision loss. Current standard care relies on anti-VEGF therapies, though some patients demonstrate inadequate response to existing treatments.
Faricimab's dual mechanism of action, targeting both VEGF-A and angiopoietin-2 (Ang2), offers a novel therapeutic approach. The drug received approval in Japan in March 2022, with clinical use beginning in May 2022.
"While clinical trials such as YOSEMITE and RHINE have demonstrated the efficacy and safety of faricimab, real-world data is essential to validate these findings in diverse patient populations and clinical settings," the researchers noted.
Study Limitations and Future Directions
The investigators acknowledged several limitations, including the small sample size, variability in treatment protocols between cases, and relatively short follow-up period. The study population included patients with diverse diabetic retinopathy stages and DME types, reflecting real-world clinical complexity.
Patient demographics showed a mean age of 63 ± 15 years, with mean HbA1c levels of 7.7 ± 1.2% in the naïve group and 7.2 ± 0.9% in the switched group. Sixteen of 22 eyes had previous panretinal photocoagulation history.
The researchers plan to continue longitudinal follow-up with additional cases to provide more robust long-term efficacy and safety data. This ongoing research will help establish optimal dosing strategies and identify patient characteristics that predict treatment response.
The study's findings support faricimab as an effective treatment option for DME in clinical practice, particularly for treatment-naïve patients, while demonstrating anatomical benefits across all patient groups regardless of previous treatment history.
