BRIEF—Sylentis efficacy study of the drug did not meet the primary endpoint

Sylentis, a wholly owned subsidiary of Spain’s PharmaMar, (has obtained the results of the Phase III SYL10111_V (tivanisiran) clinical trial for the treatment of dry-eye associated with Sjögren’s syndrome.

The primary endpoint was to evaluate the efficacy (signs and symptoms) and was not met.

The trial was a randomized, double-masked, placebo-controlled study conducted in more than 40 hospitals in the United States and 8 in Spain involving 203 patients.

Last December, Sylentis released results of the FYDES clinical trial evaluating the long-term safety of tivanisiran.

Analysis of the primary endpoint showed that the overall frequency and percentage of  patients experiencing at least one adverse event (ocular or non-ocular, related or unrelated) was similar in both treatment groups: 40.4% in the tivanisiran group and 39.8% in the control arm.