Fluocinolone Acetonide Implant Met Primary Phase 3 Endpoint for Noninfectious Posterior Uveitis
Treatment of noninfectious posterior uveitis with a fluocinolone acetonide implant (Medidur, pSivida) prevented disease recurrence at a higher rate than sham injection, thus meeting the primary endpoint in a phase 3 clinical trial, according to a company press release.
Researchers in a phase 3 multicenter, double-masked trial randomly assigned patients to treatment (n = 87) or sham (n = 42). At 6 months, more patients in the sham group (78.6%) showed disease recurrence than in the treatment group (18.4%; P < .001).
In the treatment group, 27.6% of treated eyes showed an increase of intraocular pressure (IOP) to greater than 21 mm Hg, compared with 16.7% in the control group. Through 6 months, 2.3% of eyes in the treatment group required incisional surgery to reduce IOP, and no control eyes required such surgery. Of 64 eyes phakic at baseline, 9.5% of eyes in the treatment group required cataract surgery, and 4.8% of eyes in the control group required cataract surgery.