Real-world data from the TRUCKEE and TAHOE studies, presented at the Euretina congress in Amsterdam, demonstrate the positive and stable outcomes of faricimab in patients with wet age-related macular degeneration (AMD) and diabetic macular edema (DME). These independent U.S.-based studies included both treatment-naive and switch patients, without specific exclusion criteria, providing insights into faricimab's performance beyond clinical trial settings.
Rapid Anatomic Improvements
According to Arshad M. Khanani, MD, MA, FASRS, Director of Clinical Research at Sierra Eye Associates, a single injection of faricimab resulted in rapid improvement in key anatomic parameters, including intraretinal fluid (IRF), subretinal fluid (SRF), and pigment epithelial detachment (PED), in both treatment-naive and previously treated patients with neovascular AMD and DME. In treatment-naive patients (145 eyes), the TRUCKEE study showed rapid improvement in anatomy, as highlighted by central subfield thickness (CST) and PED reductions, along with a trend toward increased vision.
Switching from Aflibercept
Data from 2250 eyes in the TRUCKEE study revealed that patients switching from aflibercept to faricimab experienced significant improvements in anatomy, with decreases in CST and PED height. Vision remained stable in these previously treated patients. Specifically, after six injections of faricimab in 219 eyes switched from aflibercept, there was an almost 50 μm improvement in CST, indicating clinically significant improvement in patients who were on frequent aflibercept treatments before switching to faricimab.
TAHOE Study: DME Outcomes
The TAHOE study, focusing on real-world evidence in DME, involved 140 eyes. Results showed improvement in CST after a single faricimab injection. Interestingly, the interval between visits for DME patients was longer (approximately 100 days) compared to AMD patients (approximately 45 days), suggesting potential adherence challenges in DME management.
Clinical Cases
Dr. Khanani presented clinical cases illustrating faricimab's effectiveness. One case involved a patient with bilateral neovascular AMD showing active disease in both eyes with IRF, SRF, PEDs, and hemorrhage. After a single faricimab injection, rapid improvement in anatomy was observed, with stable vision. Another case highlighted a treatment-naive DME patient with severe vision loss and disease, demonstrating significant anatomic improvement after a single faricimab injection.
Potential for Extended Treatment Intervals
Most patients switching from aflibercept 2 mg to faricimab experienced a reduction in anatomic parameters along with stable or improved vision, suggesting the potential for extended treatment intervals in both nAMD and DME. In the TRUCKEE study, 1007 eyes switched from aflibercept to faricimab showed improvement in anatomic parameters and stable visual acuity. Approximately 25% to 30% of patients experienced resolution of IRF and SRF after one injection of faricimab.
These real-world findings support the use of faricimab as a valuable treatment option for patients with wet AMD and DME, offering rapid anatomic improvements, stable vision, and the potential for reduced treatment burden due to its dual inhibition of VEGF-A and Ang-2.
