February 12, 2008
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Implantable device for sustained release of cyclosporine may be future of immunosuppression

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BARCELONA — An implantable device for the sustained delivery of cyclosporine over 1 year may be a valuable method of preventing graft failure, allowing for greater tissue drug levels and reduced side effects, according to a surgeon speaking here at the winter meeting of the European Society of Cataract and Refractive Surgeons.

"Cyclosporine is the most commonly prescribed immunomodulator, with the longest clinical track record. It is a potent immunosuppressant, unique for its T-cell specificity and low myelotoxicity. Its topical use, however, has been complicated by poor solubility, lack of bioavailability and poor patient tolerance," said Michael Belin, MD, of Albany Medical College in New York.

A multicenter trial involving 25 U.S. sites and eight German sites is ongoing to test the safety and efficacy of implantable cyclosporine in a silicone matrix for preventing corneal graft rejection or graft failure in patients who have experienced one or more rejection episodes.

"This implant provides sustained release of the drug for at least 1 year. Concentration at local level is at least 2 log units higher than that provided by either topical or systemic administration, while systemic levels are below the limits of detection. Silicone, on the other hand, is highly biocompatible, as proved by many trials," Dr. Belin said.

The implant has an initial high release of the drug, followed by a slow delivery over 1 year.

"Implantable cyclosporine may be the future," he said.