June 2023
Volume 64, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2023
FARETINA-DME- Early Treatment Patterns and Outcomes in Patients with Diabetic Macular Edema Treated with Faricimab: an IRIS RegistryTM Analysis
Author Affiliations & Notes
  • David Tabano
    Genentech Inc, South San Francisco, California, United States
  • Durga S Borkar
    Duke University Eye Center, South San Francisco, California, United States
  • Vincent Garmo
    Genentech Inc, South San Francisco, California, United States
  • Jacqueline K. Shaia
    Center for Ophthalmic Bioinformatics, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, United States
    Case Western Reserve University School of Medicine, Cleveland, Ohio, United States
  • Blanche Kuo
    Center for Ophthalmic Bioinformatics, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, United States
    Case Western Reserve University School of Medicine, Cleveland, Ohio, United States
  • Rachel Myers
    Verana Health, San Francisco, California, United States
  • Andrew LaPrise
    Verana Health, San Francisco, California, United States
  • Theodore Leng
    Verana Health, San Francisco, California, United States
    Byers Eye Institute, Stanford University School of Medicine, Palo Alto, California, United States
  • Rishi P Singh
    Center for Ophthalmic Bioinformatics, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, United States
  • Footnotes
    Commercial Relationships   David Tabano Genentech Inc., Code E (Employment); Durga Borkar Allergan/AbbVie, Glaukos, Iveric Bio, Code C (Consultant/Contractor); Vincent Garmo Genentech Inc., Code E (Employment); Jacqueline Shaia None; Blanche Kuo None; Rachel Myers Verana Health, Code E (Employment); Andrew LaPrise Verana Health, Code E (Employment); Theodore Leng Astellas; Consultant: Alcon, Astellas, Roche/Genentech, Apellis, Graybug, Nanoscope, Regeneron, Verana Health, Protagonist Therapeutics, Code F (Financial Support); Rishi Singh Aerie, Apellis, Graybug; Consultant: Alcon, Bausch + Lomb, Genentech, Inc., Gyroscope, Novartis, Regeneron, Code F (Financial Support)
  • Footnotes
    Support  This study was supported in part by the NIH-NEI P30 Core Grant (IP30EY025585), Unrestricted Grants from The Research to Prevent Blindness, Inc., and Cleveland Eye Bank Foundation awarded to the Cole Eye Institute. Additional funding provided by F. Hoffmann-La Roche Ltd. for the study
Investigative Ophthalmology & Visual Science June 2023, Vol.64, 2699. doi:
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      David Tabano, Durga S Borkar, Vincent Garmo, Jacqueline K. Shaia, Blanche Kuo, Rachel Myers, Andrew LaPrise, Theodore Leng, Rishi P Singh; FARETINA-DME- Early Treatment Patterns and Outcomes in Patients with Diabetic Macular Edema Treated with Faricimab: an IRIS RegistryTM Analysis. Invest. Ophthalmol. Vis. Sci. 2023;64(8):2699.

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

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Abstract

Purpose : Anti-Vascular Endothelial Growth Factor (VEGF) intravitreal agents are the standard of care for diabetic macular edema (DME), and require frequent injections. Faricimab is the only bispecific antibody for intraocular use that independently binds and neutralizes both angiopoietin-2 and VEGF-A. Limited real-world data exists on treatment patterns and outcomes of faricimab. This analysis describes the largest real-world evaluation of injection frequency and clinical response of DME patients initiating faricimab.

Methods : FARETINA-DME is a retrospective real world study using data from the IRIS registry. Data was analyzed February-August 2022 to identify faricimab starts among patients diagnosed with DME. Rules-based text search using regular expression keywords was used to identify faricimab use. Patients with ≥ 12 months of electronic health record data prior to initiation and known laterality were included. Patients receiving ≥ 4 faricimab injections were included in injection intervals and best documented visual acuity (BDVA) analyses. Injection intervals were categorized as “extended” if any interval was >6 weeks apart.

Results : 2,367 eyes (1,894 patients) were treated with faricimab for DME, with a mean (SD) of 2.4 (1.3) faricimab injections over a mean (SD) of 55.2 (48.0) days of follow-up. 410 (17.3%) of eyes were anti-VEGF treatment naïve; 1,957 (82.7%) were previously treated. Most (65.3%) previously treated eyes were treated with aflibercept. Nearly half of eyes (45% treatment naïve; 48% previously treated) had 20/40 or better BDVA at faricimab initiation.

84 (20.5%) treatment naïve and 375 (19.2%) previously treated eyes received ≥ 4 injections. Mean (SD) change in BDVA after 4 injections was 1.0 (10.1) letter for previously treated eyes and 4.6 (10.2) letters in treatment naïve eyes. Among eyes who received ≥ 4 injections, 51 (60.7%) of treatment naïve eyes (238 (63.5%) of previously treated eyes) had ≥1 “extended” injection interval among the initial 4 injections.

Conclusions : Over 2,300 eyes were treated with faricimab for DME in the US through August 2022. Among eyes with ≥ 4 injections, vision stability was observed while a majority of eyes began extending treatment intervals during four initial doses. Early treatment extensions may indicate a positive anatomical response to faricimab in DME patients.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.

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