pSivida, Bausch & Lomb study shows Retisert implant slows progression of diabetic retinopathy

By Lisa Kerner

Erie, Pa., April 3 - pSivida Ltd. said additional two-year trial results of Bausch & Lomb's two randomized trials of the Retisert implant demonstrated that 30% of eyes receiving standard of care (repeat laser treatment) had a worsening of their diabetic retinopathy compared with only 10% of eyes receiving a Retisert implant.

pSivida said Retisert also reduced retinal thickening involving the fovea (the part of the macula responsible for sharp, central vision) and led to a statistically significant three line improvement in vision, according to a company news release.

The trials were designed to evaluate the safety and efficacy of the Retisert implant in releasing fluocinolone acetonide in the management of diabetic macular edema (DME), a subset of diabetic retinopathy and a leading cause of vision loss for Americans under the age of 65.

Bausch & Lomb, exclusive licensee of Retisert from pSivida, conducted the studies of 277 patients in U.S. hospitals.

The trial results were presented at the 6th International Symposium on Ocular Pharmacology and Therapeutics in Berlin on March 30, according to a company news release.

"We believe the finding that sustained release fluocinolone acetonide can slow or reduce the progression of diabetic retinopathy is important and may have significant implications for Retisert and Medidur," chief executive officer Gavin Rezos said in the release.

Retisert is approved as a 30-month treatment for chronic non-infectious posterior segment uveitis, a sight-threatening condition affecting some 175,000 people in the United States and an estimated 800,000 people worldwide.

Three year results of the Retisert in DME trial will be presented in May, pSivida said.

pSivida is a global bio-nanotech company based in Boston.

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