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Pharmaceuticals / Submissions and Approvals

EU Green Lights Allergan’s Eye-Drug Ozurdex

Sept. 10, 2014

Allergan’s drug-releasing eye implant Ozurdex picked up a new indication in the European Union.

The dexamethasone-releasing intravitreal implant will now be available for patients with visual impairment caused by diabetic macular edema (DME) who already have an artificial lens and can’t tolerate corticosteroids.

Approval was based on two three-year, multicenter, randomized studies that looked at the proportion of patients with improvement of at least 15 letters in best-corrected visual acuity baselines.

The product is injected directly into the vitreous of the eye, where the local fluid dissolves the implant. As it dissolves, it releases dexamethasone, which works to reduce swelling and inflammation.

Ozurdex already is approved in the EU for macular edema in patients with retinal vein occlusion and for non-infectious uveitis. In the U.S., it is available for DME patients with artificial lenses or who are scheduled for cataract surgery.

The company claims that DME is a major cause of vision loss in patients with diabetes, affecting some 8.5 percent of the EU population in 2013, and expected to rise to 10.3 percent by 2035. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.