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Fluocinolone acetonide enters phase 3 trial for diabetic macular edema

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ATLANTA — An implant being developed for the treatment of diabetic macular edema has completed a 900-patient enrollment in a phase 3 trial, the implant’s developer said in a press release.

Alimera Sciences’ Medidur implant uses fluocinolone acetonide to treat diabetic macular edema. The masked, randomized, multicenter study will follow the 900 patients for 36 months. Patients have been enrolled in both the United States and Europe, the company said. Patients will receive the implant, “which is small enough to be injected through a needle during an in-office procedure and is expected to provide sustained delivery of fluocinolone acetonide to the back of the eye for up to 3 years,” according to the release.

Alimera is developing the implant in conjunction with Control Delivery Systems, the release said. In February 2005, the two companies announced a worldwide agreement to co-develop and market Medidur using fluocinolone acetonide to treat diabetic macular edema. Alimera also has the rights to develop an additional three products using the Medidur delivery system.