Allergan is recalling Ozurdex Intravitreal Implant 700㎍ (ingredient: dexamethasone), a steroid eye implant for macular edema, after detecting a foreign substance in some products
The Ministry of Food and Drug Safety said it confirmed that imports of Ozurdex products contained a foreign material.
Ozurdex is implanted in the vitreous of the eye to treat macular edema following branch retinal vein occlusion (BRVO), diabetic macular edema, and noninfectious uveitis with inflammation of the posterior segment of the eye.
Recalled products have manufacturing numbers E77093(2015-11-13), E78320(2016-04-21), E79222(2016-09-13), E80414(2017-02-15), E81571(2017-07-24), and E82657(2018-01-10).
Dexamethasone, the major ingredient of Ozurdex, inhibits inflammation and vascular endothelial growth factor (VEGF), the cause of macular edema.
Allergan won local approval for Ozurdex in 2011.
In May, the company released the results of a phase-3 study COBALT that confirmed the treatment’s efficacy in rapid visual improvement and reduction of macular edema with fewer doses, compared to VEGF inhibitors.
The 12-month study tested the dexamethasone intravitreal implant in 71 patients with macular edema following BRVO who has had the disease for less than three months. In a week after the treatment, patients had 70 percent of maximum treatment response (visual improvement and reduction of macular edema).