Positive Phase IIa dose-ranging study for PharmaMar’s SYL1801

Sylentis, a wholly-owned subsidiary of Spanish drugmaker PharmaMar (MSE: PHM), announced top-line results from the SYL1801-II study, a Phase IIa dose-ranging trial evaluating SYL1801, an investigational siRNA therapy administered via eye drops unlike other treatments which require intravitreal injection, for the treatment of neovascular age-related macular degeneration (nAMD).

The double-blinded study evaluated three parallel dose level cohorts of SYL1801 in treatment-naïve eyes of nAMD patients though 42 days. A total of 99 subjects were enrolled across 21 centers in Europe.

The primary endpoint was to evaluate the effect of SYL1801 on the change from baseline to the final visit (end of treatment) in BCVA (Best Corrected Visual Acuity) score. All dose-levels of SYL1801 maintained visual acuity similarly throughout the duration of the study. The middle concentration of 25mg/ml achieved a statistically significant improvement of visual acuity at 42 days (p=0.045).