Sylentis starts Phase III of SYL1001 to treat dry eye disease

Sylentis S.A. (Madrid, Spain) began the Phase III HELIX trial of SYL1001 to treat moderate to severe dry eye disease. The double-blind, vehicle-controlled, European trial will enroll about 300 patients. The trial is evaluating a single eye drop of 11.25 mg/mL SYL1001 ophthalmic solution given once daily.

The co-primary endpoints are the change from baseline in visual analog scale (VAS) scores for eye discomfort, corneal fluorescein staining (CFS) total scores and conjunctival hyperemia scores. The secondary endpoint is safety...