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

nistration may provide the patient with exposure to sirolimus for up to approximately three months.

In addition to safety and tolerability data, the study provided an initial assessment of sirolimus' biological activity in DME. At 45 and 90 days following treatment, patients receiving the two lowest doses of sirolimus by subconjunctival injection demonstrated mean improvements in visual acuity of 8.5 and 7.4 letters over baseline, respectively, using a standard (ETDRS) eye chart. Additionally, this group of patients also experienced anatomical improvements, with a mean decrease in foveal thickness that was consistent with the observed functional improvements in visual acuity. Preliminary data for these patients at 180 days following treatment suggest that these initial improvements in visual acuity and foveal thickness reductions were maintained, or even enhanced, over time in many patients.

"The fact that we are seeing measures of biological activity maintained, and, in some cases improving, through 180 days following a single subconjunctival injection, is somewhat surprising. This finding raises the possibility that sirolimus may be fundamentally changing the course of diabetic retinopathy through its impact on the mTOR (mammalian target of rapamycin) pathway rather than simply reversing macular edema in a more non-specific way," said Dr. Blumenkranz. "Further studies to support or refute this hypothesis will be necessary. However, if so, then the potential clinical utilization of the drug may eventually extend beyond those patients with clinically significant diabetic macular edema."

"The study's findings are intriguing, particularly in light of the fact that a majority of the participants had been previously treated for DME. As such, these results provide great excitement for researchers as we prepare to advance this product into Phase 2 clinical studies," stated David A. Weber, Ph.D., president and chief executive officer of MacuSight. "We are
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SOURCE MacuSight, Inc.
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