Sirolimus looks promising in DME

October 23, 2007

MacuSight has announced positive interim data from a Phase I study of its proprietary formulation of sirolimus (originally known as rapamycin) for the treatment of chronic, clinically significant diabetic macular oedema (DME).

MacuSight has announced positive interim data from a Phase I study of its proprietary formulation of sirolimus (originally known as rapamycin) for the treatment of chronic, clinically significant diabetic macular oedema (DME).

The randomized, open-label study of 50 subjects with DME was designed to investigate the safety, tolerability and biological activity of sirolimus delivered either by subconjunctival or intravitreal injection. The trial included ten treatment arms with subjects receiving one of five doses.

At 45 and 90 days post-treatment, subjects receiving the two lowest doses by subconjunctival injection showed mean improvements in visual acuity (VA) of 8.5 and 7.4 letters, respectively. This group also demonstrated anatomical improvements, with a mean decrease in foveal thickness consistent with the observed functional improvements in VA.

Preliminary data at 180 days post-treatment, suggests that initial improvements in VA and foveal thickness reductions are maintained or enhanced over time in many patients.

MacuSight has already completed enrolment of a second Phase I trial, which will examine sirolimus in patients with exudative age-related macular degeneration.

Sirolimus is a potent, broad-acting compound that has demonstrated the ability to combat disease through multiple mechanisms of action including immunosuppressive, anti-angiogenic, anti-migratory, anti-proliferative, anti-fibrotic and anti-permeability activity.