MacuSight initiates 30-patient sirolimus trial

MacuSight, a USA-based developer of therapeutics for the treatment of severe ocular conditions, has initiated a Phase I study of its lead product candidate in patients with wet age-related macular degeneration. This trial, which will enroll a total of 30 patients, is designed to evaluate the safety and tolerability of MacuSight's proprietary formulation of sirolimus, an immunosuppressant also known as rapamycin, when administered in various doses through two different types of ocular injections.

Investigators for this randomized, open-label, dose-escalation study will treat patients with a single subconjunctival or intravitreal injection of MacuSight's formulation of sirolimus, which is marketed as Rapamune by US drug major Wyeth. The trial will include six treatment arms with patients receiving one of three doses of sirolimus via subconjunctival injection or one of three doses via intravitreal injection. Each administration will provide the patient with exposure to the compound for up to approximately three months, MacuSight noted.