Author: Arshad Khanani
Co-authors: Tyler Ewing, Hannah Khan, Aamir Aziz, Adam Wadsworth, Huma Khan, Humza Sulahria, Ohidul Mojumder, Aigerim Saulebayeva
Abstract
TITLE: Real World Efficacy and Safety of Faricimab in Neovascular AMD and DME: The TRUCKEE StudyABSTRACT BODY:
Purpose: Faricimab was FDA approved in January 28, 2022 for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) in 2022. This multi-center real-world retrospective study evaluated the safety and efficacy of faricimab in patients diagnosed with nAMD and DME.
Setting/Venue: Clinic setting.
Methods: In this multi-center retrospective study, both treatment-naïve patients and patients switched to faricimab from other anti-VEGF agents are evaluated. Information being collected includes demographics, number of previous treatments if applicable, ETDRS visual acuity, central subfield thickness (CST) and changes in pigment epithelial detachments (PED), if applicable. Improvements in PED height and retinal fluid are evaluated as a proportion of patients. Improvements in visual acuity, CST and PED height are evaluated as averages. Adverse events related to faricimab will be collected. Observed and calculated data will be reported.
Results: Due to the recent approval of faricimab in January 28, 2022, this study is currently ongoing.
A total of 16 eyes were evaluated prior to treatment with faricimab thus far, 13 of which were diagnosed with nAMD and 3 of which were diagnosed with DME. The mean [SEM] age of nAMD and DME subjects is 80.23 [2.90] years and 76.33 [4.48] years, respectively. 15 of the 16 eyes were previously treated with other anti-VEGF therapies, the majority being aflibercept, prior to switching to faricimab. 1 of the 16 eyes was treatment naïve. The average ETDRS data and CST values have been collected at baseline for all subjects. Eyes diagnosed with nAMD have an average ETDRS score of 55.69 [5.42] letters and an average CST value of 462.62 [44.56] µm. Eyes diagnosed with DME have an average ETDRS score of 52.43 [16.81] letters and average CST value of 390.67 [59.16] µm. No adverse events related faricimab have been reported.
Of the 16 eyes, 2 eyes (1 DME and 1 nAMD) have completed one follow-up visit (1-2 weeks post-injection). The two follow-up visits indicate an average decrease in CST values by 120 µm. As further data is collected, statistical significance will be determined.
Conclusions: Patients currently afflicted by nAMD and DME suffer from a high treatment burden of frequent intravitreal injections. The frequency of injections, along with a shortage of physicians, leads to sub-optimal responses in patient vision outcomes when translated to real-world care. Faricimab intends to function as a durable agent by decreasing the frequency of treatment while maintaining stable vision, anatomy and safety for patients. Data from the TRUCKEE study will evaluate the safety and efficacy of faricimab for patients in the real-world treatment setting. Further studies are needed to continue evaluating real-world efficacy and safety outcomes in patients treated with faricimab.