Long-Acting Implant Shows Promise for Patients with Non-Infectious Uveitis
According to a study published in the journal Ophthalmology an injectable fluocinolone acetonide (FAi) long-acting implant may be able to effectively control intraocular inflammation, as well as improve visual acuity, in patients with a history of recurrent noninfectious intermediate uveitis, posterior uveitis, or panuveitis.
Duke University researchers set out to determine the effect of the implant by conducting a non-comparative, interventional, dose-randomized, dose-masked, prospective, individual, investigator-sponsored investigational new drug study.
Eleven study patients with a history of recurrent noninfectious intermediate uveitis, posterior, or panuveitis were included in the study. They were randomized to either a low- or high-dose FAi. The 11 eyes were observed on Day 0 (implant injected) and then regularly through 2 years. Main study outcome measures included ocular inflammation, visual acuity, anti-inflammatory medication use, and safety parameters prior to and after implantation.
Mean study eye visual acuity improved significantly from 0.56 logarithm of the minimum angle of resolution (logMAR) to +0.25 logMAR (P=0.041) at 12 months, and to +0.17 logMAR (P=0.016) at 24 months post-implantation. The average number of inflammation recurrences in the 12 months prior to implantation was 1.54 episodes per eye but none of the study eyes had a recurrence during the follow-up period.
The dosage was reduced in four of the six study patients who continued receiving systemic medication post-implantation. An average of 1.6 Sub-Tenon triamcinolone acetonide (PSTA) injections were administered to 5 of 11 eyes in the 12 months prior to implantation but no PSTA injections were required after FAi implantation.
In addition, the most common adverse event was a rise in intraocular pressure (IOP). The elevated IOP was managed by conventional methods.
Study authors concluded that "it is feasible to place a long-acting FAi in an outpatient setting without prolonged adverse events attributed to the implant injection procedure." The FAi implant may be a promising option for patients with noninfectious intermediate uveitis, posterior uveitis, or panuveitis who do not respond to, or are intolerant to, conventional treatment, they added.
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