Faricimab Effective, Durable in Real-World DME Outcomes

Bispecific antibody treatments remain a promising treatment for diabetic macular edema (DME), as a new study shows that faricimab was effective and had durable results after a year of real-world analysis.¹ Central subfield thickness (CST) and visual acuity both improved in patients using faricimab.

Although anti-vascular endothelial growth factor (anti-VEGF) medications have been vital in treating DME, they also require frequent appointments to receive injections, as frequently as monthly.² Faricimab, an angiopoietin-2 and VEGF-A bispecific antibody, can be used to treat DME and has an extended interval of 12 weeks or more after 1 year,¹ which could be beneficial to those who cannot go to more frequent appointments. The treatment has been approved by the FDA, but real-world data is needed to determine if this is a beneficial treatment in the long term. This study aimed to evaluate patients with DME who initiated the use of faricimab from February 2022 to March 2023 and had 12 or more months’ worth of follow-up.

The current research is based on the FARETINA-DME study, which used data from the American Academy of Ophthalmology Intelligent Research in Sight Registry, which collects data from ophthalmology practices in the US. Patients were treated with faricimab from February 2022 to March 2023 with a follow-up through March 2024. The index date for each participant was considered the first date of injection.

Patients were considered if they had at least 12 months’ worth of data in the registry before they began using faricimab, had 12 or more months of follow-up, and had at least 2 measures of visual acuity either on or after the first injection of faricimab. Patients also included those that were treatment-naïve or had received treatment in the past. Any patient who used another anti-VEGF therapy after faricimab was excluded from the study. Injections of faricimab were administered between 14 and 42 days apart, going from every 4 weeks in the first 4 doses to extending the dosage time in clinical practice.

There were 5490 patients and 7698 eyes that were included, of which 970 eyes were treatment naïve and 6728 eyes had been previously treated. The previously treated eyes had a mean (SD) of 5.6 (2.8) injections of anti-VEGF treatment in the year prior to their first injection of faricimab. Aflibercept 2 mg was the most common treatment used prior to faricimab.

The mean follow-up was 485.1 (86.3) days for treatment-naïve patients and 487.5 (92.0) days for previously treated patients. The mean number of faricimab injections was 5.4 (2.9) in treatment-naïve eyes and 6.6 (2.7) in previously treated eyes in the year after the first injection. All eyes had more frequent injections in the first 6 months of treatment compared with the second period of 6 months. Extended dosing intervals of more than 42 days were found in 64.8% of treatment-naïve eyes and 63.4% of previously treated eyes after 1 to 2 injections.

The mean visual acuity was 62.5 (19.9) letters and 65.8 (17.2) letters at baseline. Treatment-naïve eyes had a mean visual acuity of 64.1 (18.8) letters after 7 injections, whereas previously treated eyes had a mean visual acuity of 65.6 (18.0) letters after 7 injections. Previously treated eyes had stable numbers of patients with a visual acuity of 20/40 or better, whereas the proportion of treatment-naïve eyes that had 20/40 vision improved from 51.2% to 58.2%.

There were CST data available for 1336 eyes, of which 86 were treatment naïve and 1250 were previously treated. The mean CST was 343.6 (103.6) μm and 361.1 (128.9) μm at index for treatment-naïve and previously treated eyes. Both groups saw improvement in CST after using faricimab, with a mean improvement of –48.7 (82.7) μm in treatment-naïve eyes and –50.7 (101.1) μm in previously treated eyes, both after 7 injections. Controlled status was found in 42.3% of the treatment-naïve eyes and 43.8% of the previously treated eyes after 7 injections. A safety analysis found that faricimab was safe across both groups.

There were some limitations of this study. Standardized measures of visual acuity were not included in the electronic health record data. Only a subset of patients had anatomical outcomes measured. Different machine types may lead to variability in CST measures. The reason for certain dosing intervals was not included in the data. Rates of safety events per injection may have been underestimated. Potential complications of injections were not assessed. The patients included in this study may have more difficult forms of DME, which could affect the results. The use of intravitreal steroids was not recorded.

“These data support the clinical effectiveness, safety, and extended durability of faricimab in clinical practice in the United States and suggest the potential to extend treatment intervals and reduce the burden of DME treatment on patients, caregivers, and the health care system,” the authors concluded.

References

1. Singh RP, Tabano DC, Borkar DS, et al. One-year real-world outcomes and durability with faricimab in patients with diabetic macular edema. Ophthalmic Surg Lasers Imaging Retina. Published online October 30, 2025. doi:10.3928/23258160-20250825-02

2. Aderman CM, Garg SJ. Intravitreal anti-VEGF injection treatment algorithms for DME. Retina Today. July/August 2017. Accessed November 4, 2025. https://retinatoday.com/articles/2017-july-aug/intravitreal-anti-vegf-injection-treatment-algorithms-for-dme