FDA approval for non-infectious uveitis drug

Oct 08, 2010

Allergan has been given FDA approval for its drug Ozurdex (dexamethasone intravitreal implant) 0.7 mg for the treatment of non-infectious ocular inflammation.

Allergan has been given FDA approval for its drug Ozurdex (dexamethasone intravitreal implant) 0.7 mg for the treatment of non-infectious ocular inflammation.

The drug was assessed in a 26 week, multi-centre, double-masked, randomized clinical study in which 77 patients received Ozurdex 0.7mg and 76 patients received sham injections.

After a single injection of Ozurdex, the percentage of patients reaching a vitreous haze score of zero (being no inflammation) was statistically significantly greater for patients in the Ozurdex treated group versus sham at the week eight primary endpoint. In addition, the percentage of patients achieving a 3-line improvement in BCVA was 43 per cent in the Ozurdex treated group, versus 7 per cent for the sham group at week eight.

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