Sirolimus to be tested in DME patients

Union City, CA-MacuSight Inc. is beginning a phase I study of its lead product candidate in patients with diabetic macular edema (DME).

The trial, which has enrolled 30 patients, will test the safety and tolerability of MacuSight's proprietary formulation of sirolimus (originally known as rapamycin) when administered in various doses through two types of ocular injections.

The randomized, open-label, dose-escalation study will treat patients with a single subconjunctival or intravitreal injection of the sirolimus formulation.

She said it also will reduce permeability and "down-regulate" the genes involved in the inflammatory processes related to DME.