Sylentis Fails Phase 3 Trial of RNAi-based Drug Candidate for Dry Eye Associated with Sjögren's Syndrome

Sylentis, a subsidiary of Spain-based PharmaMar, announced that its phase 3 SYL10111_V (RNAi-based tivanisiran) clinical trial for the treatment of dry eye disease associated with Sjögren’s syndrome did not meet its primary endpoint—the signs and symptoms of DED.

The trial was a randomized, double-masked, placebo-controlled study involving 203 patients in in more than 40 hospitals in the United States and 8 in Spain. The trial’s main goals measured change from baseline in corneal fluorescein staining and dry-eye symptoms, according to an entry on ClinicalTrials.gov. 

According to Sylentis' website, Tivanisiran, also known as SYL1001, is a small interfering RNA that inhibits the synthesis of transient receptor potential V1 (TRPV1), which is involved in the patho-physiology of dry eye disease.