Ocular Therapeutix’s dry eye disease insert fails in phase 2 trial
Ocular Therapeutix declared that its OTX-CSI (cyclosporine intracanalicular insert) for dry eye disease (DED) has flunked to reach the primary endpoint in the phase 2 clinical trial.
The company has conducted the US-based, randomised, double-masked, multi-centre and vehicle-controlled clinical trial to evaluate the safety, tolerability, durability, and efficacy of two different formulations of OTX-CSI.
It was designed to be carried out by assessing signs and symptoms of dry eye disease in 140 subjects treated in both eyes over nearly 16 weeks. Ocular Therapeutix had administered OTX-CSI in 147...