Allergan Gains FDA Approval for Ozurdex to Treat Noninfectious Posterior Uveitis

FDA cleared Allergan’s Ozurdex® 0.7 mg for noninfectious ocular inflammation, or uveitis, affecting the posterior segment of the eye. Ozurdex is a biodegradable implant that delivers an extended release of the corticosteroid dexamethasone via intravitreal injection with Allergan’s Novadur® solid polymer delivery system.

Ozurdex is also available to physicians and patients in the EU. It was initially approved in June 2009 for the treatment of macular edema following retinal vein occlusion.

The efficacy of Ozurdex for the treatment of noninfectious uveitis affecting the posterior segment of the eye was assessed in a 26-week, multicenter, double-masked, randomized clinical study in which 77 patients received the drug and 76 patients received sham injections. Eligible patients had noninfectious ocular inflammation of the posterior segment with intermediate or posterior uveitis, a vitreous haze grade of >+1 on the 0–4 classification scale, and best corrected visual acuity (BCVA) of 10 to 75 letters on the Snellen eye chart.

After a single injection of Ozurdex, the percent of patients reaching a vitreous haze score of zero (where a score of zero represents no inflammation) was statistically significantly greater for patients in the Ozurdex-treated group versus sham (47% versus 12%, respectively) at the week-eight primary endpoint. In addition, the percentage of patients achieving a 3-line improvement in BCVA was 43% in the Ozurdex-treated group versus 7% for the sham group at week eight.