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James C Lai; Prior steroid response as a predictor of real-world IOP safety with 0.2 µg/day fluocinolone acetonide (FAc) in diabetic macular edema (DME) therapy. Invest. Ophthalmol. Vis. Sci. 2018;59(9):4828.
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Increased IOP is a commonly-reported adverse event with intravitreal corticosteroid treatment. The 0.2 µg/day FAc implant is approved by the FDA for patients who have been previously treated with a course of corticosteroids that did not result in a clinically significant increase in IOP. Real-world IOP data from PALADIN, USER, and the Medisoft safety audit were analyzed to assess the IOP signals before and after the FAc implant.
PALADIN and USER are real-world, post-approval, multicenter studies capturing up to 36 months’ clinical data pre- and post-FAc implant. Patients enrolled in these studies received 0.2 µg/day FAc per the US labeled indication. A subgroup of patients that met the US label was identified in the Medisoft Safety Audit database. IOP data and IOP events before and after 0.2 µg/day FAc implant administration were compared to determine the effect of 0.2 µg/day FAc implant administration on IOP in patients treated according to the US label indications.
IOP data from the ongoing PALADIN study are consistent with data from the USER study, despite a smaller patient population (Figure). Both the PALADIN and USER studies show similar IOP levels following treatment with the 0.2 µg/day FAc implant compared with IOP measures prior to 0.2 µg/day FAc treatment. IOP events were also similar between the two studies, and show no significant difference between the incidence of IOP events pre- and post-0.2 µg/day FAc implant administration (Table). These results are further confirmed by the findings of the Medisoft audit, which highlighted that IOP response to prior steroid could be used to predict the likelihood of IOP response to the 0.2 µg/day FAc implant.
IOP data from the PALADIN and USER studies support the role of the US label in mitigating the risk of uncontrolled IOP rise. This analysis expands the body of evidence for real-world IOP safety.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
Figure: IOP data before and after treatment with the 0.2 µg/day FAc implant in the PALADIN and USER studies
Table: Incidence of IOP-related events before and after treatment with the 0.2 µg/day FAc implant in the PALADIN and USER studies
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