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A dexamethasone 0.7 mg intravitreal implant now is approved for treatment of non-infectious uveitis affecting the posterior segment of the eye.
Irvine, CA-A dexamethasone 0.7 mg intravitreal implant (Ozurdex, Allergan) now is approved for treatment of non-infectious uveitis affecting the posterior segment of the eye.
The dexamethasone intravitreal implant has been available in the United States since June 2009, when it was approved as the first drug therapy indicated for the treatment of macular edema (ME) following retinal vein occlusion (RVO).
The dexamethasone is contained in a proprietary, biodegradable, solid polymer delivery system (Novadur, Allergan) that provides about 6 months of therapy, delivering dexamethasone in an initial pulse followed by gradual release of the remaining drug content.
The multicenter pivotal trial demonstrating the safety and efficacy of the dexamethasone intravitreal implant for the treatment of non-infectious uveitis affecting the posterior segment had a randomized, double-masked design. It included 77 patients who received the 0.7 mg dexamethasone intravitreal implant and 76 control patients treated with a sham injection. Patients were 18 years or older and had chronic intermediate or posterior uveitis with a vitreous haze grade of +1 on a scale ranging from 0 to 4 and Snellen best-corrected visual acuity (BCVA) ranging from 10 to 75 letters.
The proportion of patients achieving a vitreous haze score of 0 (no inflammation) at week 8 was assessed as the primary efficacy measure, and this endpoint was achieved at a significantly higher rate in the dexamethasone implant group compared with controls, 47% versus 12%.
At 8 weeks, 43% of patients receiving the dexamethasone implant had a 3-line or greater improvement from baseline BCVA compared with only 7% of the sham group.
"These are remarkable results considering both the rapidity and level of response, and I was similarly impressed by the efficacy of the dexamethasone intravitreal implant when I participated as an investigator in an earlier posterior segment uveitis study," said Dr. Foster, clinical professor of ophthalmology, Harvard Medical School, Boston. "Although, as a treating physician, I was not a masked examiner. In seeing patients during follow-up visits, it was very obvious who was in the dexamethasone implant group versus among the controls."