US-based Ocular Therapeutix has initiated a Phase III clinical programme to assess the safety and efficacy of its sustained release dexamethasone for treatment of post-operative inflammation and pain following cataract surgery.
Dexamethasone, an ophthalmic corticosteroid, is given as a one-time, bioabsorbable intracanalicular plug for release of the steroid to the ocular surface for up 30 days.
About 240 patients undergoing clear corneal cataract surgery will be enrolled in the first of two prospective, multicentre, randomised, parallel-arm, double-masked, vehicle-controlled trials, which will be carried out at sites across the US.
After surgery, patients will be given either the dexamethasone treatment group or a placebo vehicle plug.
The trial’s primary endpoints are absence of anterior chamber cells at day 14 and reduction of pain at day eight.
Normally physicians prescribe topical steroids post-operatively for the treatment of ocular inflammation and pain but patients do not reliably self-administer these drops, which could lead to greater or more persistent inflammation and subsequently affect visual outcomes, the company said.
Ocular Therapeutix president and CEO Amar Sawhney said: "A single-dose corticosteroid can help manage issues of compliance by putting dosing into the hands of the physician and avoiding up to four drops per day and a tapering regimen, which is confusing for the patient.
"We look forward to the completion of this trial, and continuing on to the second Phase III trial later this year."
The company is developing its proprietary absorbable polyethylene glycol hydrogel intracanalicular plug technology to release drugs in a sustained fashion over a specified period of time depending on the drug and its corresponding therapeutic need.
According to the company, at the end of the treatment period, the plug is designed to absorb and exit the nasolacrimal system without need for removal by the physician.
Ocular is focused on the development and commercialisation of ophthalmic therapeutic products using its proprietary hydrogel technology and its first product, the ReSure Sealant, was approved by FDA in January 2014 for the prevention of post-operative fluid egress following cataract surgery.