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MacuSight receives clearance to develop liquid sirolimus drug

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UNION CITY, Calif. — The Food and Drug Administration had granted MacuSight Inc. clearance to begin phase 1 clinical trials of sirolimus for treating exudative age-related macular degeneration and diabetic macular edema, the company announced in a press release.

Sirolimus, also known as rapamycin, is an immunosuppressant drug with antiangiogenic, antiproliferative and antimigratory activity. Wyeth currently markets a sirolimus formulation for preventing organ rejection following renal grafting under the brand name Rapamune.

The MacuSight release said the company believes the drug's broad range of activity may make it useful as both a front-line and a preventative treatment for wet AMD and diabetic macular edema. Company officials expect to initiate trials of its liquid sirolimus formulation for treatment of diabetic macular edema in the third quarter of this year and trials for wet AMD in the fourth quarter, according to the release.