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June 18, 2009

FDA Approves First-of-its-Kind OZURDEX

Allergan has received US Food and Drug Administration (FDA) approval for OZURDEX (dexamethasone intravitreal implant) 0.7mg, as the first drug therapy for the treatment of macular edema. OZURDEX is a first-of-its kind therapy administered via intravitreal injection delivering dexamethason

By cms admin

Allergan has received US Food and Drug Administration (FDA) approval for OZURDEX (dexamethasone intravitreal implant) 0.7mg, as the first drug therapy for the treatment of macular edema.

OZURDEX is a first-of-its kind therapy administered via intravitreal injection delivering dexamethasone, a highly potent corticosteroid, via Allergan’s proprietary and innovative NOVADUR solid polymer delivery system.

Allergan vice-president of R&D and chief scientific officer Scott Whitcup said that OZURDEX is the first injectable, sustained-release, potent steroid implant that provides prolonged efficacy and a favourable safety profile.

“In clinical studies, 20–30% of patients suffering from this severe retinal condition experienced a three-line improvement in best-corrected visual acuity with an onset of effect within the first two months following therapy,” said Whitcup.

OZURDEX is a treatment for macular edema following branch retinal vein occlusion or central retinal vein occlusion.

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