Photodiagnosis and photodynamic therapy · 2025
Real-world data of verteporfin-related ocular adverse events: A disproportionality analysis.
СтатьяНазвание и аннотация: Перевод в очереди
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Caglayan Duman Nesrin, Uzun Aslihan
Аннотация
AIM/BACKGROUND: To investigate verteporfin-induced ocular adverse events (AEs) by analysing real-world data reported in the US Food and Drug Administration's Adverse Event Reporting System (FAERS) database.
METHODS: The OpenVigil 2.1-MedDRA-v24 disproportionality analysis software package, including the Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) algorithms, was used to detect potential ocular AEs associated with verteporfin and to determine signal intensity. AE reports related to verteporfin as the primary suspect in the FAERS database between 01 January 2004 and 31 December 2024 were included in the study. The signal strengths were classified as low, medium and strong according to the ROR and PRR values.
RESULTS: The most reported preferred terms (PTs) were 'visual acuity reduced' (n = 212), 'retinal haemorrhage' (n = 100), and 'choroidal neovascularization' (n = 77). However 'polypoidal choroidal vasculopathy' (ROR=3538.345, PRR=3420.433), 'subretinal fibrosis' (ROR=3376.777, PRR=3283.005) and 'macular scar' (ROR=2458.542, PRR=2414.169) had the highest signal strength. The results of disproportionality analysis of PTs with 3 or more 'eye disorder' reports associated with verteporfin (n = 52), revealed 40 strong, 7 moderate, and 5 weak signal intensities.
CONCLUSION: The most common verteporfin-related ocular AEs (reduced visual acuity, retinal haemorrhage and choroidal neovascularization) were consistent with the drug label. However dozens of new potential ocular AEs with strong signal strengths that were not listed in the drug label, were identified. It should be noted that the proportional data in the study cannot provide information about other drugs used for the same indications as verteporfin. A fully-comprehension of these AEs will be highly beneficial in deciding which patients should be closely monitored for verteporfin-related ocular AEs. However, we emphasis our view that this study should be supported by prospective, clinically conducted research, as data on verteporfin's therapeutic indications and dosage are unavailable in this study.
METHODS: The OpenVigil 2.1-MedDRA-v24 disproportionality analysis software package, including the Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) algorithms, was used to detect potential ocular AEs associated with verteporfin and to determine signal intensity. AE reports related to verteporfin as the primary suspect in the FAERS database between 01 January 2004 and 31 December 2024 were included in the study. The signal strengths were classified as low, medium and strong according to the ROR and PRR values.
RESULTS: The most reported preferred terms (PTs) were 'visual acuity reduced' (n = 212), 'retinal haemorrhage' (n = 100), and 'choroidal neovascularization' (n = 77). However 'polypoidal choroidal vasculopathy' (ROR=3538.345, PRR=3420.433), 'subretinal fibrosis' (ROR=3376.777, PRR=3283.005) and 'macular scar' (ROR=2458.542, PRR=2414.169) had the highest signal strength. The results of disproportionality analysis of PTs with 3 or more 'eye disorder' reports associated with verteporfin (n = 52), revealed 40 strong, 7 moderate, and 5 weak signal intensities.
CONCLUSION: The most common verteporfin-related ocular AEs (reduced visual acuity, retinal haemorrhage and choroidal neovascularization) were consistent with the drug label. However dozens of new potential ocular AEs with strong signal strengths that were not listed in the drug label, were identified. It should be noted that the proportional data in the study cannot provide information about other drugs used for the same indications as verteporfin. A fully-comprehension of these AEs will be highly beneficial in deciding which patients should be closely monitored for verteporfin-related ocular AEs. However, we emphasis our view that this study should be supported by prospective, clinically conducted research, as data on verteporfin's therapeutic indications and dosage are unavailable in this study.