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Allergan intravitreal implant Ozurdex gets FDA approval

Allergan’s Ozurdex (dexamethasone intravitreal implant) 0.7mg has received approval from the US Food and Drug Administration (FDA) for the treatment of non-infectious ocular inflammation, or uveitis, affecting the posterior segment of the eye.

Ozurdex, a biodegradable implant, delivers an extended release of the corticosteroid dexamethasone through intravitreal injection with Allergan’s proprietary Novadur solid polymer delivery system.

Ozurdex’s efficacy for the treatment of non-infectious uveitis affecting the posterior segment of the eye was assessed in a 26-week, multi-center, double-masked, randomised clinical study in which 77 patients received Ozurdex 0.7mg and 76 patients received sham injections.

After a single injection of Ozurdex, the percent of patients reaching a vitreous haze score of zero was statistically significantly greater for patients in the Ozurdex treated group versus sham (47 versus 12%, respectively) at the week eight primary endpoint.

Allergan Research and Development executive vice president and chief scientific officer Scott Whitcup said that the approval of Ozurdex offers physicians another option to treat ocular inflammation resulting from uveitis affecting the posterior segment of the eye.