October 04, 2007
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Sirolimus improved vision, reduced foveal thickness in phase 1 DME trial

UNION CITY, Calif. — A phase 1 study shows that MacuSight's sirolimus was safe and well-tolerated in patients with chronic, clinically significant diabetic macular edema, the company announced in a press release. The drug improved visual acuity and reduced foveal thickness in these patients, the release said.

Investigators reviewed outcomes for 50 patients treated with one of five doses of sirolimus (rapamycin) delivered by subconjunctival or intravitreal injection. They observed no evidence of increased IOP or inflammatory response to treatment, the release said.

Additionally, at 45 and 90 days follow-up, patients receiving the two lowest doses of sirolimus by subconjunctival injection showed mean improvements in visual acuity of 8.5 and 7.4 letters over baseline, respectively.

Preliminary data for these patients at 180 days follow-up also suggest that many patients maintained their improvements in visual acuity and foveal thickness, according to the release.

MacuSight has completed enrollment for its second phase 1 trial, which is examining the effects of sirolimus in patients with exudative age-related macular degeneration. Results are expected to be released in the first half of 2008.