FDA Approves Implant to Treat Diabetic Macular Edema

The FDA has approved Ozurdex, a biodegradable steroid implant for use in patients with diabetic macular edema (DME) who already have an artificial lens implant or who are about to undergo cataract surgery.

Ozurdex uses a sustained-release biodegradable solid polymer delivery system to reduce DME-causing inflammation in the eye, replacing the need for monthly injections.
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Ozurdex originally won approval for use in patients with macular edema after branch retinal vein occlusion and noninfectious uveitis affecting the posterior segment of the eye in 2009 and 2010, respectively.

Approval came after Ozurdex was shown to increase the proportion of patients with a 15-letter or more improvement in best-corrected visual acuity in 2 multicenter, 3-year clinical trials.  

Common side effects include cataracts and elevated intraocular pressure.

–Michael Potts

Allergan. Allergan announces R&D pipeline update and US FDA approval [press release]. June 30, 2014. http://agn.client.shareholder.com/releasedetail.cfm?ReleaseID=857025 Accessed July 1, 2014.