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| |  FDA Approves Dexamethasone Intravitreal Implant for Macular Oedema NEW YORK -- June 18, 2009 -- The US Food and Drug Administration (FDA) has approved dexamethasone intravitreal implant (Ozurdex) 0.7 mg for the treatment of macular oedema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). The efficacy of dexamethasone intravitreal implant was assessed in 2 multicentre, double-masked, randomised parallel studies involving approximately 1,300 patients. In each individual study and in a pooled analysis, time to achieve a >= 15 letter (3-line) improvement in best-corrected visual acuity (BCVA) cumulative response rate curves were significantly faster with the dexamethasone implant compared with sham (P < .01), with dexamethasone-treated patients achieving a 3-line improvement in BCVA earlier than sham-treated patients. The onset of effect with the dexamethasone implant defined as a >= 15 letter (3-line) improvement in BCVA, occurred within the first 2 months after implantation in approximately 20 to 30 percent of patients. The duration of effect persisted approximately 1 to 3 months after onset. "This new therapy provides physicians with a meaningful advancement in treating RVO, offering a convenient option to patients through its unique extended delivery profile," Mark S. Blumenkranz, MD, Department of Ophthalmology, Stanford University, Palo Alto, California. Dexamethasone intravitreal implant will be administered as an in-office procedure. The treatment is expected to be available to physicians and patients in the United States in the third quarter of 2009. Dexamethasone intravitreal implant is contraindicated in patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis, vaccinia, varicella, mycobacterial infections, and fungal diseases. It is also contraindicated in patients with advanced glaucoma and in patients with known hypersensitivity to any components of this product or to other corticosteroids. The most common ocular adverse reactions reported by > 2% of the patients in the first 6 months included increased intraocular pressure (25%), conjunctival haemorrhage (20%), eye pain (7%), conjunctival hyperemia (7%), ocular hypertension (4%), cataract (4%), vitreous detachment (3%), and headache (3%). SOURCE: Allergan, Inc.
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