This trial is designed to evaluate the safety and tolerability of MacuSight’s proprietary formulation of sirolimus when administered in various doses through two different types of ocular injections.
Sirolimus is a compound that has demonstrated the ability to combat disease through multiple mechanisms of action. Based on the versatility associated with these multiple mechanisms of action, MacuSight believes that its sirolimus product may serve as a potentially highly-efficacious therapeutic for a wide range of ocular diseases, including the treatment and prevention of wet AMD.
“Not only does sirolimus inhibit the production, signaling and activity of many cellular factors reported to be relevant to the development of DME, it can also reduce permeability and down-regulate the genes involved in the inflammatory processes that are a key part of the pathophysiology of diabetic retinopathy.” stated Julia Haller, Professor of Ophthalmology at the Wilmer Institute.
MacuSight has developed a minimally-invasive, sustained administration approach for its liquid sirolimus formulation which it believes will provide the product with significant competitive advantages related to convenience, ease of use, compliance and safety.
The company intends to initiate the phase I wet AMD trial during the fourth quarter of 2006.