Investigative Ophthalmology & Visual Science Cover Image for Volume 65, Issue 7
June 2024
Volume 65, Issue 7
Open Access
ARVO Annual Meeting Abstract  |   June 2024
The Real-World Efficacy and Safety of Faricimab in Diabetic Macular Edema: The TAHOE Study
Author Affiliations & Notes
  • Huma Khan
    Sierra Eye Associates, Reno, Nevada, United States
    University of Nevada Reno, Reno, Nevada, United States
  • Hannah Khan
    University of Nevada, Reno School of Medicine, Reno, Nevada, United States
  • Aamir A Aziz
    University of Nevada, Reno School of Medicine, Reno, Nevada, United States
  • Greggory Gahn
    Sierra Eye Associates, Reno, Nevada, United States
  • Mark Rami Barakat
    Retinal Consultants of Arizona, Phoenix, Arizona, United States
  • Giulia Corradetti
    Doheny Eye Institute, Pasadena, California, United States
  • Carl J Danzig
    Rand Eye Institute, Deerfield Beach, Florida, United States
  • Jordan M Graff
    Barnet Dulaney Perkins Eye Center, Phoenix, Arizona, United States
  • Jared Nielsen
    Wolfe Eye Clinic, West Des Moines, Iowa, United States
  • Jeremy Wolfe
    Associated Retinal Consultants, Royal Oak, Michigan, United States
  • SriniVas R Sadda
    Doheny Eye Institute, Pasadena, California, United States
  • Arshad M. Khanani
    Sierra Eye Associates, Reno, Nevada, United States
    University of Nevada, Reno School of Medicine, Reno, Nevada, United States
  • Footnotes
    Commercial Relationships   Huma Khan None; Hannah Khan Genentech, Code E (Employment); Aamir Aziz REGENXBIO, Code E (Employment); Greggory Gahn None; Mark Barakat Alcon, Allegro, Allergan, Alimera, Bausch & Lomb, Clearside Biomedical, Eyepoint Pharmaceuticals, Kodiak Sciences, Genentech, Novartis, Ocular Therapeutix, REGENXBIO, Adverum Biotechnologies, Regeneron, Graybug, Palatin Technologies, AbbVie Inc, Apellis, Arctic Vision, Biogen, Coherus Biosciences, Opthea, Outlook Therapeutics, Roche, Code C (Consultant/Contractor), Clearside Biomedical, Eyepoint Pharmaceuticals, Kodiak Sciences, Genentech, Roche, Oxurion, REGENXBIO, Adverum Biotechnologies, Graybug, Annexon Biosciences, Gemini Therapeutics, Gyroscope Therapeutics, Ocular, Oculis, Opthea, ReNeuron, Stealth Biotherapeutics, Unity Biotechnology, Code F (Financial Support), NeuBase, Oxurion, RevOpsis Therapeutics, Code I (Personal Financial Interest); Giulia Corradetti None; Carl Danzig Genentech, Roche, Regeneron, Bayer, Adverum, REGENXBIO, Allergan, Novartis, Iveric Bio, Code C (Consultant/Contractor), Genentech, Roche, Regeneron, Bayer, Adverum, Kodiak, Unity, REGENXBIO, Novartis, Iveric Bio, Alexion, Gyroscope, Code F (Financial Support); Jordan M Graff Genentech, Code C (Consultant/Contractor); Jared Nielsen Alcon, Iveric Bio, Genentech, and Regeneron, Code C (Consultant/Contractor), Alexion, Bayer, EyePoint Pharmaceuticals, Gemini Therapeutics, Genentech, Gyroscope Therapeutics, Iveric Bio, Kodiak Scientific, Novartis, NovoNordisk, Regeneron, REGENXBIO, and Roche, Code F (Financial Support); Jeremy Wolfe Allergan, Novartis, Genentech, Regeneron, Code C (Consultant/Contractor), Allergan, Novartis, Genentech, Regeneron, Code F (Financial Support); SriniVas Sadda 4DMT, Alexion, Allergan, Alnylam Pharmaceuticals; Amgen, Apellis Pharmaceuticals, Astellas, Bayer Healthcare Pharmaceuticals, Biogen, Boehringer Ingelheim, Carl Zeiss Meditec, Catalyst Pharmaceuticals, Centervue, Roche/Genentech, Gyroscope Therapeutics, Heidelberg Engineering, Iveric Bio, Janssen Pharmaceuticals, Merck & Co., Nanoscope, Novartis, Optos, Oxurion/ Thrombogenics, Pfizer, Regeneron Pharmaceuticals, Samsung Bioepis, and Vertex Pharmaceuticals, Code C (Consultant/Contractor); Arshad Khanani Abbvie, Adverum Biotechnologies, AGTC, Alimera Sciences, Allergan, Apellis Pharmaceuticals, Arrowhead, Pharmaceuticals, AsclepiX Therapeutics, Aviceda Therapeutics, Bausch & Lomb , BroadWing Bio, Cholgene Therapeutics, 4D Molecular Therapeutics, Eyepoint Pharmaceuticals, Fronterra Therapeutics, Gemini Pharmaceuticals, Genentech, Graybug Vision, Gyroscope Therapeutics, Iveric Bio, Janssen Pharmaceuticals, Kato Pharmaceuticals, Kartos Therapeutics, Kodiak Sciences, Kriya Therapeutics, Ocular Therapeutix, Oculis, Ocuterra, Opthea, Oxurion, Novartis, Perfuse, PolyPhotonix, Ray Therapeutics, Recens Medical, Regeneron Pharmaceuticals, REGENXBIO, Roche, Stealth Biotherapeutics Therapeutics, Thea Pharma, UNITY Biotechnology, Vanotech, Code C (Consultant/Contractor), Adverum Biotechnologies, Annexon Biosciences, Apellis Pharmaceuticals, AsclepiX Therapeutics, 4D Molecular Therapeutics, Gemini Pharmaceuticals, Genentech, Graybug Vision, Gyroscope Therapeutics, Iveric Bio, Janssen Pharmaceuticals, Kodiak, Neurotech, NGM Biopharmaceuticals, Novartis, Ocular Therapeutix, Oculis, Ocuterra, Opthea, Oxurion, Recens Medical, REGENXBIO, Roche, UNITY Biotechnology, Code F (Financial Support), Aviceda Therapeutics, PolyPhotonix, Recens Medical, Code I (Personal Financial Interest)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2024, Vol.65, 6259. doi:
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      Huma Khan, Hannah Khan, Aamir A Aziz, Greggory Gahn, Mark Rami Barakat, Giulia Corradetti, Carl J Danzig, Jordan M Graff, Jared Nielsen, Jeremy Wolfe, SriniVas R Sadda, Arshad M. Khanani; The Real-World Efficacy and Safety of Faricimab in Diabetic Macular Edema: The TAHOE Study. Invest. Ophthalmol. Vis. Sci. 2024;65(7):6259.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Faricimab was FDA-approved for diabetic macular edema (DME) in January 2022. This multi-center, prospective study evaluates the safety and efficacy of faricimab in real-world patients diagnosed with DME.

Methods : This study investigates both treatment-naive patients and patients that switched to faricimab from other anti-VEGF agents. Data collected included demographics, treatment history, best-corrected visual acuity (BCVA), central subfield thickness (CST), and presence of subretinal or intraretinal fluid (SRF or IRF). Snellen visual acuity was converted to Early Treatment Diabetic Retinopathy Study (ETDRS) scoring. Improvements in visual acuity and CST are evaluated as averages. Improvements in retinal fluid are evaluated as a proportion. Observed and calculated data is reported. Safety is summarized.

Results : A total of 181 eyes across 136 patients were recorded. The average age was 69.2 years; 50.7% were male and 21.5% had switched from aflibercept. A total of 756 injections have been recorded. All eyes post one injection of faricimab (n=140) had a BCVA increase of +2.16 letters (p=0.353) and a CST decrease of -36.16 um (p=0.066). All eyes post three injections of faricimab (n=94) had a BCVA increase of +3.78 letters (p=0.146), a CST decrease of -45.28um (p=0.052). No cases of intraocular inflammation, endopthalmitis, vasculitis or retinal artery occlusion have been observed.

Conclusions : Faricimab has demonstrated efficacy via anatomic and visual parameters in both treatment-naive and previously treated patients, a demographic not studied in the trials leading to FDA-approval. No safety cases related to inflammation have been observed. Future results will continue to investigate the long term safety, efficacy and durability of faricimab in real-world patients with DME. Latest data will be presented at ARVO 2024.

This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.

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