Allergan ($AGN) announced that the FDA has approved the company's Ozurdex sustained-release biodegradable implant to treat diabetic macular edema (DME). The expanded indication means the therapy, based on a proprietary delivery system, is approved for use in the general DME population, not just those with an artificial lens implant or in need of cataract surgery.
"Allergan is committed to developing innovative treatment options that address unmet patient needs, and retinal diseases such as DME are extremely difficult to manage," said Allergan Chief Scientific Officer Dr. Scott Whitcup. "We are pleased that the updated indication supports the use of Ozurdex to help improve vision for more patients with DME."
Ozurdex delivers 0.7 milligrams of the corticosteroid dexamethasone intravitreally (within the eye) using the company's Novadur delivery system. The product is a solid polymer matrix that releases the medication and biodegrades into lactic acid and glycolic acid, according to the Allergan website. It administered by injection in an in-office procedure using the product's applicator, which is preloaded with the implant.
The approval was based on a three-year randomized sham-controlled clinical trial of improvement in best-corrected visual acuity, according to the release. Allergan says DME affects more than 560,00 Americans, and results in blurred vision and eventually blindness.
The Ozurdex implant is also used to treat to macular edema noninfectious uveitis, according to the release.
- read the release
- here's more about the delivery system