Talisa E. de Carlo Forest, MD
Medical Director of Imaging
University of Colorado
Dr. Jeremy Wolfe of ARC in Royal Oaks, Michigan presented LATE-BREAKING real-world data on faricimab use in the TRUCKEE Study. This bispecific antigen received FDA approval earlier this year for use in neovascular age-related macular degeneration (AMD) and diabetic macular edema. The TRUCKEE Study endeavors to present the efficacy, durability, and safety of this novel therapeutic outside of the sterile clinical trial environment.
The TRUCKEE Study has so far enrolled 491 patients (550 eyes) who have receiving a total of 1,231 intravitreal faricimab injections. 355 patients had at least one follow-up visit after faricimab injection and 89 patients had follow-up after three faricimab injections. 37 patients were treatment-naïve prior to initiating faricimab. 298 patients had previously been treated, with over half of these receiving Aflibercept as their most recent anti-VEGF injection.
After one injection of faricimab there was an average gain of 0.7 ETDRS letters and an improvement in central subfoveal thickness (CST) and pigment epithelial detachment (PED) height of 25.3uM and 58.9um respectively. Dr. Wolfe pointed out that the treatment interval prior to the first faricimab injection was 44.2 days – closely matching the follow-up interval of 43.5 days. This clinical improvement was maintained and further augmented in those patients with follow-up after three faricimab injections. Vision improved an average of 3.0 ETDRS letters from baseline and CST and PED height were reduced by 43.3um and 63.6um. It was not reported if patients who only had follow-up after one faricimab injection were switched back to another medication due to poor response or simply didn’t have follow-up to the three month mark yet. However, Dr. Wolfe does plan to investigate what happens to patients who are switched back to other anti-VEGF drugs in the future. Safety data was promising, demonstrating that of the 1,231 injections there was one culture-positive infectious endophthalmitis and one case of intraocular inflammation without vasculitis detected on fluorescein angiography. I look forward to hearing the results of this important real-world study at future meetings when longer follow-up and switch-back data is available.