pSivida, Alimera to start international Medidur phase 3 trials

By Elaine Rigoli

Tampa, Fla., June 7 - pSivida, Ltd. and Alimera Sciences Inc. announced that regulatory agencies in the United Kingdom, Canada and India have approved the start of phase 3 clinical trials of the Medidur device for the treatment of diabetic macular edema (DME).

These international clinical sites are opening in conjunction with the sites already underway in the United States, according to a news release.

The Medidur development plan has already been granted fast-track status by the Food and Drug Administration.

Medidur, a tiny injectable device, delivers the steroid fluocinolone acetonide directly to the back of the eye and is designed to treat DME, a leading cause of vision loss in people below 65 years of age worldwide, the release said.

pSivida is a global bio-nanotech company with headquarters in Perth, Australia.

Alpharetta, Ga.-based Alimera develops over-the-counter and prescription ophthalmology pharmaceuticals.

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