September 30, 2014

FDA Approves Two Extended-Release Drug Therapies For DME

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FDA Approves Two Extended-Release Drug Therapies For DME

By Dan Roberts
Implants devised by two different companies for treatment of diabetic macular edema (DME) have been approved by the FDA for use in the United States. The companies are Allergan and Alimera, and the new drugs are Ozurdex and Iluvien respectively.
Both drugs are corticosteroids that have demonstrated effectiveness in the treatment of DME without the need for monthly injections. Tiny implants injected into the eye’s vitreous gel release the steroids into the retina over a period of years, greatly relieving the burden of multiple clinic visits.
Ozurdex is also indicated for treatment of macular edema following retinal vein occlusion, and for the treatment of non-infectious uveitis.
Iluvian is also being studied as a treatment for dry macular degeneration (geographic atrophy), but concerns by the FDA about safety and manufacturing standards have slowed its progress toward clinical trials.
Due to the high risk of cataract development and glaucoma, both extended-release steroid treatments are limited to adults without elevated intraocular pressure (IOP) and those who either have undergone, or are scheduled for, cataract surgery. Both therapies should be available in clinics by early 2015.

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