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MacuSight(TM) Announces Positive Preliminary Results From Phase 1 Study of Sirolimus in Wet Age-Related Macular Degeneration
Date:2/25/2008

Sirolimus Demonstrates Favorable Safety Profile and Improvements in Visual

Acuity

UNION CITY, Calif., Feb. 25 /PRNewswire/ -- MacuSight(TM), Inc., a developer of innovative therapeutics for the treatment of severe ocular diseases and conditions, today announced positive preliminary data from a Phase 1 study of its lead product candidate in patients with wet (exudative) age-related macular edema (wet AMD). Similar to its Phase 1 study in patients with diabetic macular edema (DME), preliminary results from this prospective study of 30 patients demonstrated that MacuSight's proprietary formulation of sirolimus (rapamycin) was safe and well-tolerated in all doses tested with two different routes of administration. In addition, improvements in visual acuity consistent with anatomical retinal changes were observed following a single administration of sirolimus. These findings were presented at Bascom Palmer Eye Institute's Angiogenesis, Exudation and Degeneration 2008 conference by Pravin U. Dugel, M.D., member of MacuSight's scientific advisory board, managing partner, Retinal Consultants of Arizona, Phoenix AZ, clinical instructor, vitreoretinal diseases and surgery, department of ophthalmology, University of Arizona, and the study's lead investigator.

As part of the design of this randomized, open-label study, investigators evaluated the safety, tolerability and biological activity of sirolimus when delivered by either a subconjunctival or intravitreal injection. The trial showed no evidence of increased intraocular pressure, inflammatory response to treatment, or indication of progression of cataracts. Furthermore, the study provided an initial assessment of sirolimus' biological activity in AMD with patients demonstrating improvements in visual acuity despite extended duration of disease prior to entering the study. Additionally, patients also experienced anatomical improvements as demonstrated by a reduction in
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SOURCE MacuSight, Inc.
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