Real-World Efficacy of Faricimab to Treat Diabetic Macular Edema

Results from a Japanese study investigating real-world outcomes of treating diabetic macular edema (DME) with intravitreal faricimab (IVF) have indicated faricimab’s high efficacy and effectiveness in improving both best-corrected visual acuity (BCVA) and central macular thickness (CMT) in patients.

Diabetic retinopathy, of which DME is a symptom, is the most prevalent microvascular complication in patients with diabetes. Vision loss is a common outcome of DME and is generally ascribed to retinal vascular abnormalities such as hyperpermeability, hypoperfusion, and neoangiogenesis. These eventually lead to functional and anatomical alterations in glial cells and retinal neurons. Standard anti-VEGF treatments are widely considered the most effective method of circumventing this.2

Based on data from the YOSEMITE and RHINE trials, 2 global, multicenter, randomized, double-masked, active-comparator-controlled, phase 3 trials, faricimab is considered a fully efficacious and safe treatment for DME. It is widely used as an alternative to aflibercept after a patient’s DME has proven refractory to it.1

“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,” wrote Toshiaki Hirakata, MD, PhD, department of ophthalmology, Juntendo University Faculty of Medicine, and colleagues. “This study examines the short-term real-world outcomes of faricimab in DME, focusing on its application under pro re nata (PRN) or [treat-and-extend (TAE)] regimens.”1

Hirakata and colleagues collected data on patients treated with intravitreal faricimab between July 2022 and July 2023. Patients were excluded if they could not be followed up due to complications of diseases that cause retinal exudative changes, as well as cases that self-interrupted their hospital visits. Patients with vitrectomy history were not excluded. Of the 15 PRN cases, 3 received 3 monthly loading injections and 12 did not have an induction period. Of the 7 TAE cases, 5 received 3 monthly loading injections and 2 did not.1

The study’s primary endpoint was a change in BCVA from baseline; its secondary endpoint was CMT change in optical coherence tomography (OCT) from baseline. All patients were given comprehensive ophthalmic examinations, including logarithm of the minimum angle of resolution BCVA (logMAR BCVA), inter ocular pressure (IOP), fundus ophthalmoscopy, and spectral-domain OCT (SD-OCT).1

A total of 18 patients were included in the study, with 22 consecutive eyes treated with IVF for DME. A pair of cohorts were established – treatment-naïve patients (n = 12) and patients switched from other treatments (n = 5). There were 12 male and 11 female participants; their mean age was 63 +/- 15 years, and mean hemoglobin A1c (HbA1c) at baseline was 7.7 +/- 1.2 in the naïve group and 7.2 +/- .9 in the switched group.1

At baseline, logMAR BCVA for the naïve and switched groups were .24 +/- .31 and .14 +/- .2, respectively. At the endpoint, logMAR BCVA for the naïve group was .16 +/- .26 and .08 +/- .15 for the switched group. BCVA significantly improved after IVF in the naïve group (P = .01), but remained the same after IVF treatment in the switched group (P = .31).1

CMT at baseline for the naïve and switched groups were 507 +/- 185 µm and 414 +/- 158 µm, respectively. At endpoint, however, CMT for naïve and switched groups were 359 +/- 153 µm and 341 +/- 148 µm, respectively. CMT substantially improved in both groups (naïve P = .002, switched P = .04) after IVF, and the percentage of patients with CMT <300 µm increased substantially in both groups.1

Despite the overall positive results, Hirakata and colleagues indicate potential limitations, including small sample size, variance in IVF treatment methods between cases, and a relatively short follow-up period.1

“We intend to continue this longitudinal study using additional cases,” they wrote.1

References

1. Hirakata T, Hara F, Nochi Y, et al. Short-term real-world outcomes of diabetic macular edema treated with intravitreal faricimab. PLoS One. 2025;20(5):e0323088. Published 2025 May 13. doi:10.1371/journal.pone.0323088

2. Kusuhara S, Fukushima Y, Ogura S, Inoue N, Uemura A. Pathophysiology of Diabetic Retinopathy: The Old and the New. Diabetes Metab J. 2018;42(5):364-376. doi:10.4093/dmj.2018.0182