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Allergan receives FDA approval for injectable steroid implant for reducing macular edema
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IRVINE, Calif. — The U.S. Food and Drug Administration has approved Allergan's dexamethasone intravitreal implant for reducing macular edema due to branch retinal vein occlusion or central retinal vein occlusion, the company announced in a press release.
Administered intravitreally, Ozurdex (dexamethasone intravitreal implant 0.7 mg) delivers an extended release dose of the corticosteroid to the back of the eye through Allergan's proprietary Novadur solid polymer delivery system, the release said.
The FDA approval follows positive results from two randomized, parallel, multicenter, double-masked clinical trials of the implant that enrolled approximately 1,300 patients.
In both studies, as well as in a pooled analysis, patients treated with the drug achieved a three-line improvement in best corrected visual acuity significantly faster than patients who received sham treatment; 20% to 30% of patients who received the drug experienced a three-line improvement in BCVA within the first 2 months after implantation. The duration of effect lasted approximately 1 month to 3 months thereafter, according to the release.
Allergan plans to make the drug available to physicians and patients in the United States in the third quarter.
"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," Scott Whitcup, MD, Allergan's chief scientific officer and executive vice president of research and development, said in the release.
Ozurdex is the first therapy indicated for macular edema secondary to retinal vein occlusion to receive FDA approval.