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Ozurdex effective for treatment of RVO in clinical practice
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LONDON — Ozurdex demonstrated efficacy comparable to that demonstrated in other pivotal phase 3 clinical trials for the treatment of retinal vein occlusion, according to a presenter here.
Jean-François Korobelnik, MD, presented the results of a multicenter, prospective study of the efficacy of Ozurdex (dexamethasone 0.7 mg intravitreal implant, Allergan) at the Euretina Congress.
Jean-François Korobelnik
“In 2010, the French Health Authority requested implementation of a study to monitor the outcomes of patients in clinical practice,” Korobelnik said. “The LOUVRE protocol was validated in 2011.”
The study involved 48 randomly selected centers in France: 75% private and 25% public. A total of 383 patients were treated, and 276 were evaluated at 6 months. Mean best corrected visual acuity at baseline was 47 letters.
At 6 months 47% of patients received one injection, 51% received two injections and six patients received three injections, according to Korobelnik.
“A mean gain of 6 letters was reported. This ranged from 11 letters in eyes where the onset of macular edema occurred less than 3 months previously, to only 2 when the interval between onset and treatment was longer,” Korobelnik said.
Patients who received treatment earlier had better outcomes, according to Korobelnik.
“Of the 33% of patients who gained 15 or more letters, 41% had an interval from onset to treatment of less than 3 months,” he said.
Adverse events included elevated IOP in 27% of the eyes and some degree of cataract in 12% of the eyes. IOP increased by less than 10 mm Hg in 60% of the cases, according to Korobelnik.
Disclosure: Korobelnik is a consultant to Alcon, Allergen, Bayer, Novartis, Roche, Théa and Zeiss.