Tivanisiran for the treatment of dry eye disease did not reach its primary endpoints of ocular pain and total corneal staining in the phase 3 HELIX trial, Sylentis announced in a press release.
The trial included 330 patients with moderate to severe dry eye disease treated with either tivanisiran or artificial tears once a day for 4 weeks. The primary endpoints for the study were ocular pain and total corneal staining outcomes compared between patients treated with tivanisiran or artificial tears.
According to the release, tivanisiran showed an improvement in ocular pain symptoms and signs of corneal staining with respect to baseline, but there was no statistically significant difference compared with the results of patients treated with artificial tears.
In a secondary endpoint, tivanisiran showed an improvement to the comparator (P = .035) in reducing central corneal staining after 1 month of treatment.
Several biomarkers of the disease were determined in the trial. The results indicated a superiority of tivanisiran over the comparator with a 125% increase in mucin and a 13% decrease in an inflammation marker, the release said.