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Intravitreal implant authorized in Europe to treat noninfectious uveitis
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MARLOW, U.K. — The European Medicines Agency has granted extended marketing authorization to Allergan for its dexamethasone intravitreal implant to treat noninfectious uveitis, the company announced in a press release.
Ozurdex (dexamethasone 0.7 mg intravitreal implant in applicator) was compared to sham treatment in the HURON phase 3 study, which evaluated 229 patients with noninfectious posterior segment uveitis with a vitreous haze score of at least 1.5.
"The clinical trials in patients with uveitis suggest that a single injection of Ozurdex can be effective at improving vision by controlling intraocular inflammation and is generally well tolerated with a low rate of cataract and a low rise in intraocular pressure," Sue Lightman, MD, PhD, FRCP, FRCOphth, one of the lead investigators in the HURON study, said in the release.
The 26-week study found that vitreous haze resolved completely because of reduced inflammation in approximately four times as many patients with the dexamethasone implant compared with sham treatment.
In addition, mean improvements in best corrected visual acuity and visual functioning in the treatment group were found to be statistically significant.
Ozurdex is authorized in many European countries to treat macular edema in patients with retinal vein occlusion. Allergan plans to launch the new indication to European physicians in the third quarter of 2011, according to the release.