Sirolimus safe and well tolerated in wet AMD patients

MacuSight has announced positive preliminary data from the Phase I study of its lead product candidate for wet age-related macular degeneration (AMD), sirolimus.

As part of the randomized, open-label study of 30 patients, investigators evaluated the safety, tolerability and biological activity of sirolimus when delivered by either subconjunctival or intravitreal injection. The results of the study showed no evidence of increased intraocular pressure, inflammatory response to treatment or indication of progression of cataracts. Furthermore, the study provided a preliminary assessement of the drug's biological activity in AMD, with patients demonstrating improvements in visual acuity despite extended duration of disease prior to entering the study. In addition to this, patients also experienced anatomical improvements as demonstrated by a reduction in retinal thickness.

The findings also demonstrate that sirolimus, administered via subconjunctival injection, is as effective, if not more so, than sirolimus administered via intravitreal injections. This is good news for physicians and patients since subconjunctival injections are regarded as less invasive.

MacuSight is currently preparing to intitiate a Phase II trial.