Safety

In addition to its broad activity, sirolimus has the advantage of possessing a proven safety profile. The compound is the active pharmaceutical ingredient in the FDA-approved products Rapamune^®, for prevention of organ rejection in patients undergoing renal transplants (Wyeth Pharmaceuticals, Inc.), and the CYPHER^® Sirolimus-eluting Coronary Stent, which is designed to open and maintain treated arteries in patients with coronary artery disease. As a result, sirolimus has been safely administered to humans for more than six years. Additionally, a number of derivatives of sirolimus are in late-stage clinical development as anti-cancer therapies. This established safety profile in other indications affords MacuSight significant advantages in the areas of speed of development and likelihood of clinical success.

While these approved sirolimus-containing products speak to the safety of MacuSight's compound, it should be noted that they have not been optimized as ophthalmic treatments in the same way as MacuSight's product candidate. As such, the approved formulations of sirolimus are not acceptable for ocular application due to broad systemic exposure and other important factors that impact the treatment of diseases of the eye.

• Lead Program
• Mechanisms of Action
• Safety
• Optimized Administration
• Clinical Status
• Intellectual Property

"Having been safely administered to humans for more than six years, sirolimus possesses a proven safety profile."