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Biodegradable implant shows positive results from early trial

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SUNNYVALE, Calif. — A biodegradable implant is effective in the treatment of persistent macular edema, results of a phase 2 trial show. Plans are under way to initiate phase 3 trials for the implant later this year.

A total of 306 patients were enrolled in the randomized dose-ranging study. Patients received either 350 micrograms of dexamethasone, 700 micrograms of the drug or were observed only. At 90-day follow-up, patients in the 700-microgram group gained 2 or more lines compared with the observation-only group. Additionally, patients in both treatment groups showed statistically significant decreases in both retinal thickness and fluorescein leakage.

According to manufacturer Oculex, the preliminary data revealed no major safety issues related to the Posurdex treatment. Of the patients in the two treatment groups, 4% showed a mild rise in intraocular pressure, and none of the patients showed significant progression of cataracts.