Allergan Korea said Tuesday that it has started re-marketing Ozurdex (ingredient: dexamethasone), a steroid eye implant for macular edema.
|Allergan's steroid eye implant for macular edema Ozurdex|
The company had recalled a batch of its product after detecting a foreign substance in some products in October last year. Allergan completed all of its corrective and preventive measures to ensure that no relevant issues arise.
Allergan won local approval for Ozurdex in 2011.
With the relaunch, the company will be able to treat patients with macular edema, postinflammatory noninfectious uveitis, and diabetic macular edema after branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).
Also, Ozurdex became the only treatment to receive insurance benefits for macular edema and diabetic macular edema after BRVO from December last year.
The company said it also confirmed the efficacy and safety of the treatment through completing its phase-3 study, COBALT, which established that the therapy had rapid visual improvement and reduction of macular edema with fewer doses, compared to vascular endothelial growth factor (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 the maximum treatment response (visual improvement and reduction of macular edema).