Irvine-based drug maker Allergan Inc. said the U.S. Food and Drug Administration approved its Ozurdex 0.7 mg biodegradable steroid implant for general use in treating diabetic macular edema.
The product was originally approved in June for the same condition in certain adult patients. The latest approval means it can now be used in the general patient population for diabetic macular edema.
The condition affects about 560,000 Americans with diabetes, according to a 2012 report quoted by Allergan in a statement. The condition can cause fluid leaks into the eye and causes blurred vision and eventual blindness, a second study noted.
The Ozurdex implant releases medicine to suppress inflammation that can lead to DME.
Allergan said the new approval stemmed from “ongoing review of clinical data demonstrating efficacy and safety.”
