Ozurdex approved for non-infectious uveitis

OZURDEX (dexamethasone) intravitreal implant by Allergan
OZURDEX (dexamethasone) intravitreal implant by Allergan
The FDA has approved Ozurdex (dexamethasone intravitreal implant, from Allergan) for the treatment of non-infectious ocular inflammation, or uveitis, affecting the posterior segment of the eye. This approval was based on data from a 26-week, multicenter, double-masked, randomized clinical study in which 77 patients received Ozurdex 0.7mg and 76 patients received sham injections. Eligible patients had non-infectious 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 10–75 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 percent 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.

Ozurdex is a biodegradable implant that delivers an extended release of the corticosteroid dexamethasone via intravitreal injection with Allergan's proprietary Novadur solid polymer delivery system.

For more information call (800) 433-8871 or visit www.allergan.com.