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Enrollment begins for pharmacokinetic study of Medidur fluocinolone acetonide implant

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ATLANTA — Alimera Sciences and pSivida Limited have begun enrolling patients in the first human pharmacokinetic study of the Medidur fluocinolone acetonide implant, which is being developed as a treatment for diabetic macular edema, according to a press release from the companies.

The 3-year, open-label study is designed to support the phase 3 FAME (Fluocinolone Acetonide in Diabetic Macular Edema) trial by providing pharmacokinetic and pharmacodynamic correlation data.

Investigators plan to enroll 16 patients in the trial. Samples of blood and aqueous humor will be periodically taken to assess systemic and anterior chamber drug levels, the release said.

Alimera and pSivida have a worldwide agreement to co-develop and market the Medidur implant for delivering fluocinolone acetonide to treat diabetic macular edema, according to the release.