Safety

Sirolimus and its derivatives have been safely administered to humans for more than a decade as the active pharmaceutical ingredient in multiple FDA-approved products including:

• Rapamune® for prevention of organ rejection in patients undergoing kidney transplant
• CYPHER® Sirolimus-eluting Coronary Stent to open and maintain treated arteries in patients with coronary artery disease
• TORISEL® for the treatment of advanced renal cell carcinoma
• CERTICAN® for prevention of organ rejection in patients undergoing heart or kidney transplant
• AFINITOR® for the treatment of advanced renal cell carcinoma

Sirolimus' well-established systemic safety profile, combined with its proven therapeutic benefits in non-ocular indications, position the compound as a potentially valuable treatment for various ocular diseases. However, it should be noted that the sirolimus formulations mentioned above are not suitable/safe for ocular administration.

*Rapamune and TORISEL are registered trademarks of Wyeth Pharmaceuticals, Inc.

*CYPHER is a registered trademark of Johnson & Johnson

* CERTICAN and AFINITOR are registered trademarks of Novartis Pharmaceuticals Corporation

• Sirolimus
• Therapeutic Action
• Safety
• Intellectual Property

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