Ocular Therapeutix’s Clinical Trial of Dry Eye Device Fails to Meet Primary Endpoint

Ocular Therapeutix has announced that its phase 2 clinical trial of its OTX-CSI (cyclosporine intracanalicular insert) drug-device product to treat dry eye disease failed to meet its primary endpoint.

The device part of the product is designed to deliver the drug therapy for up to 12 weeks with a single insert. The inserts, which are absorbed by the body over time, work as a hands-free alternative to traditional eyedrops.

A study of two different formulations of OTX-CSI in 140 subjects treated in both eyes over approximately 16 weeks did not meet the primary endpoint of increased tear production at 12 weeks, the company said.