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FDA approves implant for treatment of noninfectious uveitis affecting posterior segment
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IRVINE, Calif. — Patients with noninfectious uveitis affecting the posterior segment have a new treatment option after the U.S. Food and Drug Administration approved Allergan's injectable bioerodible steroid-containing implant for that indication.
Ozurdex (dexamethasone intravitreal implant 0.7 mg, Allergan) was approved in 2009 for the treatment of branch and central retinal vein occlusion and has been investigated in other potential applications. Under the ruling, the implant is now approved for use in patients with noninfectious ocular inflammation, or uveitis, affecting the posterior segment.
The approval comes after a double-masked, multicenter, randomized clinical trial demonstrated significant reductions in vitreous haze compared with sham (47% vs. 12%, respectively) at 8 weeks after a single injection. The trial investigators also reported significantly better vision in the active arm of the trial: 43% of patients treated with Ozurdex gained three or more lines of best corrected visual acuity vs. 7% in the sham arm.
"The approval of Ozurdex offers physicians another option to treat ocular inflammation resulting from uveitis affecting the posterior segment of the eye," Scott Whitcup, MD, Allergan's executive vice president, research and development, and chief scientific officer, said in a press release announcing the FDA ruling.