Allergan’s Ozurdex Granted New DME Indication
Allergan’s eye implant therapy Ozurdex can now be used on the entire diabetic macular edema (DME) patient population, following an FDA expansion of the product’s indication last week.
The agency’s decision on Ozurdex (dexamethasone intravitreal implant) was based on results of two three-year studies looking at the proportion of patients with vision improvements of 15 or more letters from baseline. The approval follows FDA’s move in June to expand the product’s indication for adults with artificial lens implants or who are scheduled for cataract surgery.
Ozurdex, a biodegradable steroid implant to reduce inflammation, originally was approved for macular edema following branch or central retinal vein occlusion. Ozurdex is the second such implant to win approval in the last two weeks, following Alimera’s Iluvien.
Pharmaceutical analysts have projected Ozurdex will generate $86 million in global sales this year and $98 million in 2015. — 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.