Sylentis' dry eye drug misses primary goals in phase 3

A phase 3 trial of Sylentis’ dry eye disease candidate tivanisiran has missed (PDF) its primary endpoints. The PharmaMar subsidiary failed to link the siRNA eye drops to improved scores on scales of ocular pain and corneal staining compared to artificial tears. Sylentis advanced tivanisiran into phase 3 in the belief that inhibiting the production of ion channels involved in the transmission of ocular pain would improve the lives of people with dry eye disease. To test that idea, investigators enrolled 330 patients and randomized them to receive daily doses of tivanisiran or artificial tears for four weeks.
The Madrid-based biotech emerged from the study with data suggesting tivanisiran is no better than artificial tears at controlling ocular pain or addressing damage to corneal cells. That resulted in the trial missing its primary endpoints. Sylentis used its release to disclose the news on other, more positive aspects of the data, starting with a statistically significant improvement in central corneal staining, a measure of cell damage. If the performance against the secondary endpoint is reproducible, it would suggest that tivanisiran is effective at improving one part, but not all, of the cornea.