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.

 

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Retina Today is a publication that delivers the latest research and clinical developments from areas such as medical retina, retinal surgery, vitreous, diabetes, retinal imaging, posterior segment oncology and ocular trauma. Each issue provides insight from well-respected specialists on cutting-edge therapies and surgical techniques that are currently in use and on the horizon.