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August 10, 2023
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BLOG: Real-world outcomes, injection patterns in DME patients treated with faricimab

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Key takeaways:

  • The FARETINA-DME study looked at faricimab real-world treatment patterns and outcomes in diabetic macular edema.
  • More than half of eyes that received at least four injections had extended injection intervals.

Faricimab is the first and only dual-pathway inhibitor approved for use in ophthalmology; specifically, it is indicated for the treatment of wet age-related macular degeneration and diabetic macular edema.

In order to assess the real-world treatment patterns and outcomes associated with the drug’s use in DME patients, my colleagues and I performed a retrospective review of electronic health record data housed in the American Academy of Ophthalmology IRIS Registry (Intelligent Research in Sight). We called our study FARETINA-DME; my coauthor David Tabano, PhD, presented the first 6 months of data from FARETINA-DME at this year’s Association for Research in Vision and Ophthalmology annual conference.

Theodore Leng, MD, MS

To execute this study, we identified DME patients who were new Vabysmo (faricimab, Genentech) users from February to August 2022, which represented the 6 months immediately following approval of faricimab. Inclusion criteria included at least 1 year of EHR data prior to initiation of faricimab and known laterality of DME. Faricimab initiation was identified by a text search of regular phrases and keywords.

We identified 2,367 eyes of 1,894 patients with DME who were treated with faricimab. The mean number of injections was 2.4, administered over a mean 55.2 days of follow-up. Among those treated, most eyes (82.7%) had previously received anti-VEGF therapy.

During our comparison of treatment-naive and previously treated eyes, we observed that:

  • Among previously treated eyes, nearly two-thirds (65.3%) had been treated with aflibercept.
  • Among eyes that were treatment naive or had been previously treated, 45% and 48%, respectively, had at least 20/40 best documented visual acuity (BDVA) at initiation of therapy.
  • Among treatment-naive eyes, 20.5% received at least four injections during the review period. A similar percentage of eyes (19.2%) in the previously treated group received at least four injections.

We determined that, in order to be included in data sets exploring injection intervals and BDVA trends, patients needed at least four faricimab injections. We defined an extended injection interval as anything that was longer than 6 weeks between doses. Among patients that received at least four injections, we found that:

  • Mean change in BDVA was 4.6 letters among treatment-naive eyes and 1 letter among previously treated eyes.
  • Extended injection intervals occurred in more than half of eyes: 60.7% of eyes that were treatment naive experienced at least one extended injection interval during the study period, as did 63.5% of previously treated eyes.
  • Extension of treatment intervals occurred early for many patients, with 74.5% and 70.1% of treatment naïve and previously treated eyes, respectively, experiencing an extension after one or two faricimab injections.

Further real-world studies that track the anatomic and functional response to faricimab dosing in DME will be needed. Still, these early data are encouraging insofar that vision stability was observed in many eyes after four faricimab injections, and a majority of eyes experienced extended injection intervals after treatment with faricimab.

Reference:

  • Tabano D, et al. Early treatment patterns and outcomes in patients with diabetic macular edema treated with faricimab: the FARETINA-DME study. Presented at: Association for Research in Vision and Ophthalmology annual meeting; April 23-27, 2023; New Orleans.
Sources/Disclosures

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Disclosures: Leng reports being a medical advisor for Verana Health.