United States Food and Drug Administration (FDA) has accepted the MacuSight's Investigational New Drug (IND) application for its proprietary formulation of sirolimus (rapamycin). The IND covers the compound's development as a treatment for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), a manifestation of diabetic retinopathy. MacuSight is in the process of setting up a Phase I clinical trial for diabetic retinopathy for third quarter of 2006.
We are pleased with the rapid progress of our ongoing efforts to develop our proprietary sirolimus drug candidate for the treatment of serious ocular diseases and conditions such as wet AMD and DME," said David A. Weber, Ph.D., MacuSight's president and chief executive officer. "The therapeutic potential for this product is very exciting and we are eager to initiate our Phase I clinical trials."
Sirolimus, originally known as rapamycin, has demonstrated the ability to combat ocular disease and conditions through multiple mechanisms of action including immunosuppressive, anti-angiogenic, anti- migratory, anti-proliferative, anti-fibrotic and anti-permeability activity. MacuSight believes that its sirolimus product may serve as a therapeutic solution.
2 comments:
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Diabetic Retinopathy Treatment
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- The Diabetic Retinopathy
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