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MacuSight(TM) Announces Positive Initial Results From Phase 1 Study of Sirolimus in Diabetic Macular Edema
Date:10/1/2007

Sirolimus Demonstrates Favorable Safety Profile and Improvements in Visual

Acuity

UNION CITY, Calif., Oct. 1 /PRNewswire/ -- MacuSight(TM), Inc., a developer of innovative therapeutics for the treatment of severe ocular diseases and conditions, today announced positive interim data from a Phase 1 study of its lead product candidate in patients with chronic, clinically significant diabetic macular edema (DME). Results from this prospective study of 50 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. Additionally investigators noted improvements in visual acuity and foveal thickness reductions for up to 180 days following a single administration of sirolimus. These findings were presented at the 40th Annual Meeting of The Retina Society by Mark Blumenkranz, M.D., chairman of MacuSight's scientific advisory board and professor and chairman of the department of ophthalmology, Stanford University School of Medicine.

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 subconjunctival or intravitreal injection. Intravitreal injections (into the central cavity of the eye), while the standard route of administration for current therapies, are uncomfortable for many patients and are accompanied by the risk of serious infection in a small percentage of patients. In contrast, subconjunctival injections (just under the outer layer over the white of the eye) are designed to offer physicians and patients a less invasive and more convenient procedure. MacuSight's DME trial included ten treatment arms with patients receiving one of five doses of sirolimus via either a single subconjunctival injection or a single intravitreal injection. Preclinical studies suggested that a single admi
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SOURCE MacuSight, Inc.
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