Allergan, Inc announced that the United States Food and Drug Administration (FDA) has approved Ozurdex (dexamethasone intravitreal implant) 0.7 mg as the first drug therapy indicated for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). Retinal vein occlusion (RVO), including BRVO and CRVO, is the second most common retinal vascular disease after diabetic retinopathy and is a significant cause of vision loss.
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. Via the Novadur delivery system, Ozurdex, a biodegradable implant which enables the extended release and effect of dexamethasone, is placed in the vitreous cavity in the back of the eye treating the macular edema associated with RVO, thereby improving a patient's visual acuity.
With Ozurdex, patients can achieve high concentrations of dexamethasone to reduce macular edema associated with RVO, while relying on the delivery of a consistent low level of dexamethasone to maintain edema control and enhance safety.
"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 three-line improvement in best-corrected visual acuity with an onset of effect within the first two months following therapy," said Scott Whitcup, Allergan's executive vice president, Research and Development and chief scientific officer. "With our nearly 60-year leadership and research investment in eye care, we are pleased to enter the retina market and provide physicians and their patients with the first FDA-approved drug treatment for macular edema following retinal vein occlusion."
The efficacy of Ozurdex was assessed in two multi-center, double-masked, randomized parallel studies involving approximately 1,300 patients. In each individual study and in a pooled analysis, time to achieve a â%¥ 15 letter (three-line) improvement in best-corrected visual acuity (BCVA) cumulative response rate curves were significantly faster with the Ozurdex implant compared to sham (p < 0.01) with Ozurdex treated patients achieving a three-line improvement in BCVA earlier than sham-treated patients.
The onset of effect with Ozurdex, defined as a â%¥ 15 letter (3-line) improvement in BCVA, occurred within the first two months after implantation in approximately 20 to 30 percent of subjects. The duration of effect persisted approximately one to three months after onset.
"RVO is a common condition in patients 40 years of age and older and if left untreated can lead to vision loss. In the United States alone, more than 150,000 new cases of RVO are diagnosed each year," said Mark S Blumenkranz, professor and chairman, department of ophthalmology, Stanford University, Palo Alto, California. "This new therapy provides physicians with a meaningful advancement in treating RVO, offering a convenient option to patients through its unique extended delivery profile."
Ozurdex 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.
Founded in 1950, Allergan, with headquarters in Irvine, California, is a multi-specialty health care company that discovers, develops and commercializes innovative pharmaceuticals, biologics and medical devices that enable people to live life to its greatest potential - to see more clearly, move more freely, express themselves more fully.