FDA approves OZURDEX implant for uveitis treatment

Sep 27 2010

Allergan, Inc. (NYSE: AGN) today announced that the United States Food and Drug Administration (FDA) has approved OZURDEX^® (dexamethasone intravitreal implant) 0.7 mg for the treatment of non-infectious ocular inflammation, or uveitis, affecting the posterior segment of the eye. Uveitis is characterized by inflammation of the eye's uvea, which is the middle vascular layer consisting of the iris (anterior), ciliary body (intermediate) and choroid (posterior). Uveitis of the anterior (front) of the uvea is more common and typically does not lead to vision impairment;while posterior uveitis (back of the eye) is associated with more severe outcomes that can include blindness, cataracts, secondary glaucoma and macular abnormalities.Posterior uveitis is the cause of 10 to 15 percent of cases of blindness in the United States.OZURDEX^® is a biodegradable implant that delivers an extended release of the corticosteroid dexamethasone via intravitreal injection with Allergan's proprietary and innovative NOVADUR^® solid polymer delivery system.

“It is also a milestone for Allergan's Retina franchise, which exemplifies our continued commitment to developing and bringing to market advanced therapies that meet the unmet medical needs of patients with difficult-to-treat retinal diseases.”

The efficacy of OZURDEX^® for the treatment of non-infectious uveitis affecting the posterior segment of the eye was assessed in a 26-week, multi-center, double-masked, randomized clinical study in which 77 patients received OZURDEX^® 0.7 mg 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 to 75 letters on the Snellen eye chart. In terms of vitreous haze, a score of +1 on the scale indicates slightly blurred optic nerve and vessels. Severity increases with each grade of the scale, with grade 4 indicating that the optic nerve head is obscured. Key exclusion criteria included history of glaucoma or use of intraocular pressure (IOP) lowering medications within the last month.

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 percent, respectively) at the week eight primary endpoint. In addition, the percent of patients achieving a 3-line improvement in BCVA was 43 percent in the OZURDEX^® treated group, versus seven percent for the sham group at week eight.

"The approval of OZURDEX^® offers physicians another option to treat ocular inflammation resulting from uveitis affecting the posterior segment of the eye," said Scott Whitcup, M.D., Allergan's Executive Vice President, Research and Development and Chief Scientific Officer. "It is also a milestone for Allergan's Retina franchise, which exemplifies our continued commitment to developing and bringing to market advanced therapies that meet the unmet medical needs of patients with difficult-to-treat retinal diseases."

OZURDEX^® is administered as an in-office procedure. The treatment is currently available to physicians and patients in the United States and the European Union. OZURDEX^® implants were initially approved in June 2009 as the first drug therapy indicated for the treatment of macular edema following retinal vein occlusion (RVO).