Move Over Macugen, Visudyne & Lucentis?

Sirna Therapeutics, Inc. (Nasdaq: RNAI), reported the final results from its completed Phase I trial for Sirna-027, a novel therapeutic for age-related macular degeneration (AMD). The Phase I study evaluated the safety, tolerability, and biological effect of single-ascending doses of Sirna-027 in patients with AMD. A total of 26 patients with active disease were enrolled to receive a single intravitreal injection of Sirna-027.

Single doses of Sirna-027 were safe and well tolerated, and all 26 patients (100%) showed visual acuity stabilization eight weeks after a single injection.

In addition, 19% of patients experienced clinically significant improvement in visual acuity. Three months after a single injection 92% of patients showed visual acuity stabilization, with 15% of patients experiencing clinically significant improvement in visual acuity. Importantly, a decrease in foveal thickness was observed in some patient groups, which is an indication of biological activity of Sirna-027 and chemically optimized siRNA's.

A Phase II trial is expected to initiate later this year.