Author: Veeral Sheth
Co-authors: Hannah Khan, Aamir A. Aziz, Ashkan M. Abbey, David R.P. Almeida, Robert L. Avery, Himanshu K. Banda, Mark R. Barakat, Ramanath Bhandari, Emmanuel Y. Chang, Carl J. Danzig, Sara J. Haug, Nikolas J.S. London, Michael A. Singer, Jeremy D. Wolfe, Arshad M. Khanani
AbstractPurpose: The FDA approved faricimab for the treatment of neovascular age-related macular degeneration (nAMD) in early 2022. Current anti-vascular endothelial growth factor (VEGF) agents improve patient outcomes in clinical trials but real-world patients show a decline in visual acuity (VA) presumably due to high treatment burden. Faricimab is intended to function with comparable efficacy to current agents while demonstrating increased durability, and is being investigated in the real-world by this real-world study.
Setting: Multi-center prospective chart review study utilizing paper charts or electronic medical records for data collection of real-world patients treated with faricimab for nAMD since FDA approval.
Methods: Prospective chart review conducted on nAMD patients treated with faricimab at least once. Treatment-naÔve patients and patients switched to faricimab from other anti-VEGF agents are evaluated. Demographics, previous treatment interval, early treatment diabetic retinopathy study (ETDRS) VA, central subfield thickness (CST), presence of retinal fluid, and presence/changes in pigment epithelial detachments (PED) are collected (if applicable). VA, CST and PED height (if applicable) are evaluated as averages. Presence of sub/intraretinal fluid (SRF/IRF) and PEDs (if applicable) are evaluated as proportions. Adverse events are collected and reported.
Results: 377 nAMD patients and 423 nAMD eyes (54% female, 46% male) were evaluated at baseline faricimab treatment. Mean age is 79.6 years. Adjusted mean baseline ETDRS of patients switched from other agents (n=217 eyes) and CST values are 62.8 letters and 327.9 µm, respectively, with an average previous treatment interval at 39.2 days. At follow-up, patients saw an average of +0.7 ETDRS letter improvement and mean CST reduction of -26.8 µm, with an average interval of 39.6 days. No cases of retinal vasculitis were observed. One case of culture-positive endophthalmitis was reported out of 770 total injections.
Conclusions: VA and CST improvements have been noted in Phase III clinical trials, demonstrating durability of faricimab in nAMD patients. Thus far, real-world patients are showing stability in VA and improvement in anatomic parameters but are still at an early time point. Faricimab will continue to be evaluated in real-world patients to evaluate efficacy and safety.
Financial Disclosure: Speaker: Genentech, Alimera, ApellisConsultant: Genentech, Novartis, Alimera, EyePoint, IvericBio, Graybug, Apellis, RegeneronContracted research: Allergan, Opthea, Oxurion, Recens Medical, Roche, Regenxbio, Eyepoint, Genentech, Ionis, Novartis, Regeneron, Santen, SamChungDang, IvericBio, Gyroscope, Chengdu Kanghong, SalutarisMD, NGM Biopharmaceuticals, Alimera Sciences, Outlook