Using sustained low-dose levels of corticosteroid can enable better control of inflammation compared to current standard of care for noninfectious uveitis of the posterior segment (NIU-PS), with fewer adjunctive medications and potentially lower doses of systemic treatment, according to research presented at the EURETINA 2021 Virtual Congress.
“Treating patients with a low-dose fluocinolone acetonide implant (FAi) significantly improved outcomes compared with patients receiving standard of care. Based on the FDA criteria for recurrence, a greater proportion of both the FAi treated eyes and the treated control eyes were free of recurrence through 3 years and the median time to first recurrence was lengthened,” reported Carlos Pavesio MD.
Prof Pavesio presented an overview of the evidence to date concerning the recurrence rates in NIU-PS, primarily based on the pivotal PSV-FAI-001 clinical trial, which demonstrated that fluocinolone acetonide in addition to standard treatment significantly reduced the proportion of patients who experienced a recurrence of uveitis in the study eye at 6 months (primary end point) in comparison to standard treatment alone.
Furthermore, recurrence remained lower at 36 months. Secondary outcomes also favoured fluocinolone acetonide over the sham injection including time to first uveitis recurrence, improvement in visual acuity, reduction in macular oedema and use of adjunctive corticosteroids or immunosuppressants.
Prof Pavesio said that the study results had implications for the optimal treatment strategy to adopt for patients with NIU-PS, a group of ocular inflammatory diseases responsible for up to 20% of blindness in the developed world.
The current standard of care is reactive administration of systemic immunosuppressants or corticosteroids, with subsequent tapering of medication once disease control is achieved, leading to cycles of remission and recurrence. Immunosuppressive drugs also carry their own potential risk of side effects, he added.
Subgroup analyses of the data from two clinical trials of fluocinolone acetonide strongly supported previous findings in terms of the drug’s ability to reduce recurrence rates and adjunctive medication requirements, noted Prof Pavesio.
In a 3-year fellow eye analysis (Eye, 2021: https://doi.org/10.1038/s41433-021-01608-9), bilateral disease was present and evaluated in 59 of 87 treated participants and outcomes were compared between FAI treated and fellow eyes in the same patients.
“The goal was to better understand both the natural history of the disease process over this time period as well as the response of the fellow eye to conventional treatments,” said Prof Pavesio.
Over 36 months, more FAi-treated than fellow eyes remained recurrence-free (28.8% versus 5.1%) and treated eyes also had fewer recurrences (mean 1.9 vs. 4.7 recurrences respectively). Treated eyes also gained an average of 9.6 letters best-corrected visual acuity compared to a loss of 4.4 letters in fellow eyes.
Summing up, Prof Pavesio said that the results of these studies confirmed that treating patients with low-dose FAi significantly improved outcomes compared with patients receiving standard of care.
“By studying the fellow eye in patients with bilateral NIU-PS, this internal control enabled the clear demonstration of the benefit of FAi beyond any systemic treatment that was administered to manage the fellow eye,” he concluded.