Allergan Receives FDA Approval For OZURDEX

Allergan has received FDA approval for OZURDEX (dexamethasone intravitreal implant) 0.7mg, as the first drug therapy for the treatment of macular edema, following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).

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, the company said.

Scott Whitcup, Vice President of R&D and Chief Scientific Officer at Allergan, said: OZURDEX represents the first injectable, sustained-release, potent steroid implant that provides prolonged efficacy and a favorable safety profile. In the clinical studies, 20 to 30 percent of patients suffering from this severe retinal condition experienced a 3-line improvement in best-corrected visual acuity with an onset of effect within the first two months following therapy2.