Safety Study of Tivanisiran to Treat Dry Eye

Phase 3 Completed 301 enrolled Sylentis, S.A.

RandomizedParallel-groupTriple-blindTreatment

Summary

This study will examine the safety of tivanisiran sodium eye drops versus vehicle when dosed once daily for 1 year in subjects with signs and symptoms of dry eye disease (DED).

Timeline

Start: 2022-03-24
Primary completion: 2023-10-11
Completion: 2023-10-11

Outcome

Met primary endpoint

release “FYDES achieved the primary endpoint of the study by demonstrating the long-term safety of tivanisiran ophthalmic solution administration.” pharmamar.com ↗

release “FYDES achieved the primary endpoint of the study by demonstrating the long-term safety of tivanisiran ophthalmic solution administration.” sylentis.com ↗

Publications

Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SYL1001	Small interfering RNA (siRNA)	—	Topical