The American Society of Retina Specialists (ASRS) meeting in Stockholm featured the presentation of the FARETINA-DME Study, which investigated the real-world effectiveness of faricimab in treating diabetic macular edema (DME). The study, led by Theodore Leng, MD, MS, a professor of ophthalmology at Stanford University, leveraged the American Academy of Ophthalmology's IRIS Registry, the world's largest specialty-specific dataset, to analyze over 7,700 eyes treated with faricimab.
Real-World Data on Faricimab in DME
Faricimab, available since January 2020, has demonstrated promising results in Phase 3 clinical trials. However, real-world data often differs due to the inclusion of diverse patient populations and varied treatment approaches. The FARETINA-DME study aimed to bridge this gap by examining how physicians utilize faricimab in everyday clinical practice.
The study included a cohort of 7,700 eyes with DME treated with faricimab between 2022 and 2023, with a 12-month follow-up period. The analysis revealed that 13% of the eyes were treatment-naive, while the majority had been previously treated with other anti-VEGF agents. Notably, 61% of previously treated eyes had been switched from aflibercept.
Injection Frequency and Anatomic Outcomes
One of the key findings was the reduction in injection frequency after switching to faricimab. Treatment-naive eyes received an average of 3.5 injections in the first six months, which decreased to approximately two injections in the subsequent six months. Previously treated eyes showed a similar trend, with an average of four injections in the first six months and 2.5 injections in the second six months. This confirms the potential for extended duration intervals with faricimab, as observed in Phase 3 trials.
Visual Acuity and CST Improvements
Anatomic data, derived from OCT scans of a subset of eyes, revealed a mean improvement of 30 microns in central subfield thickness (CST) in both treatment-naive and previously treated eyes. This finding is particularly significant, as it indicates that even eyes previously treated with other anti-VEGF agents experienced anatomic improvements after switching to faricimab.
Visual acuity outcomes also showed promise. Treatment-naive eyes gained an average of four letters from baseline, while previously treated eyes maintained their vision. This suggests that switching to faricimab may help maintain visual acuity and potentially extend the duration of therapy.
Safety and Clinical Implications
The study also addressed safety concerns, finding that the rates of side effects, complications, and infections were consistent with those reported in Phase 3 trials. This reinforces the safety profile of faricimab in real-world settings.
Dr. Leng noted that the real-world data provides confidence in using faricimab as a first-line agent for DME. The study's findings suggest that faricimab can improve anatomic outcomes, maintain or improve visual acuity, and potentially reduce the frequency of injections, offering significant benefits for patients with DME.
