Ocular Therapeutix has announced that its OTX-CSI (cyclosporine intracanalicular insert) failed to meet its primary endpoint in the Phase II dry eye disease (DED) treatment trial.
OTX-CSI, a long-acting, preservative-free cyclosporine intracanalicular insert, resides in the canaliculus and occludes the punctum.
The randomised, double-masked, multi-centre and vehicle-controlled Phase II clinical trial was conducted at 15 locations across the US.
The durability, tolerability, safety and efficacy of OTX-CSI’s two different formulations were evaluated in the trial by measuring the symptoms and signs of DED in 140 people who received treatment in both eyes over nearly 16 weeks.
OTX-CSI was given to 147 DED patients as part of the clinical trial, which was carried out by evaluating four groups.
The groups included OTX-CSI for a shorter duration (two to three months formulation-F1, n=42) and longer duration (three to four months formulation-F2a, n=40) as well as vehicle insert for a very short duration (one week formulation-F3, n=22) and longer duration (three to four months formulation-F2b, n=43).
According to the Phase II trial’s top-line data, OTX-CSI failed to meet the primary endpoint of increased tear production at 12 weeks, as measured by the Schirmer’s Test, compared to the vehicle-treated group.
The company noted that, generally, the OTX-CSI insert in both the formulations was observed to have a favourable safety profile and was tolerated well.
Ocular Therapeutix president and CEO Antony Mattessich said: “While we are disappointed by these results, demonstrating clinical benefit in patients with DED remains a significant unmet need and we will continue to review the data for additional information that may inform future development of this programme.
“We remain confident in the potential of our hydrogel-based formulation technology and its ability to deliver innovative ophthalmology therapies.
“We look forward to our anticipated Phase II top-line readout for OTX-DED for the short-term treatment of signs and symptoms of DED.”