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SCIENTIFIC PAPER

Impact of a Pharmaceutical Recall of Intravitreal Bevacizumab on Patients in the United States: A HALO Registry Review

Poster Free Paper

PRESENTING AUTHOR

Hasenin Al-khersan MD

Retina Consultants of Texas, Houston
haseninrh@gmail.com
  • Elioenai Garcia,
    University of Texas Medical Branch School of Medicine, Galveston, TX, USA
  • Kenneth C. Fan,
    Retina Consultants of Texas, Houston, TX, USA
  • Edward H. Wood,
    Austin Retina Associates, Austin, TX, USA
  • Philip Storey,
    Austin Retina Associates, Austin, TX, USA
  • Charles Wykoff,
    Retina Consultants of Texas, Houston, TX, USA
  • Purpose:

    To determine the effects of a large pharmaceutical recall of intravitreal bevacizumab (IVB) in the United States (U.S.).

  • Methods:

    Retrospective review across 19 retina practices in 16 U.S. States. Records were retrieved for patients receiving at least two IVB injections 6 months prior to a pharmaceutical recall of repackaged IVB occurring on October 2, 2023 (Pine Pharmaceuticals, Tonawanda, NY). A comparative analysis of drug administration was performed for the same interval one year prior.

  • Results:

    In total, 25,689 eyes from 20,551 patients met inclusion criteria. Of these eyes, 39.4% switched to an anti-vascular endothelial growth factor (VEGF) agent other than IVB after the recall. Eyes of uninsured patients were less likely to switch agents post recall (20.5%) compared to all other insurance types (39.5%, p<0.001). In the same interval one year prior, 29,366 eyes met the same inclusion criteria. The switch rate from IVB to other anti-VEGF agents was meaningfully lower in the year prior (7.6%, p<0.001). Importantly, 2,627 eyes (13.35%) had an increase ≥28 days in their injection interval after the recall. There was no statistically significant difference in the rate of endophthalmitis for injections given before (47 cases, rate of 0.067%) and after the recall (21 cases, rate of 0.071%, p=0.831).

  • Conclusions:

    This analysis found a meaningful change in anti-VEGF usage due to a large IVB recall, which appeared to have more pronounced consequences for uninsured populations. Additionally, our work suggests a clinically meaningful proportion of patients likely had delays in treatment due to the recall.