Bedford, mass.-based Ocular Therapeutix launched Phase III human clinical studies of its drug-releasing optical plug in patients undergoing cataract surgery.
The company plans to enroll 240 patients in a randomized, double-masked studies evaluating the safety and efficacy of its plugs for sustained-release of the steroid dexamethasone to the surface of the eye for up to 30 days. Ocular hopes to recreate success seen in earlier studies, which reported relief from pain and inflammation in patients treated with the drug-release plugs.
Ocular’s implanted plugs aim to replace traditional eye-drops, which patients often have trouble adhering to. Inconsistent use of the usual topical steroids can lead to persistent post-surgery inflammation and may affect visual outcomes of surgery, the company said.
"A single-dose corticosteroid can help manage issues of compliance by putting dosing into the hands of the physician and avoiding up to 4 drops per day and a tapering regimen which is confusing for the patient," Ocular president & CEO Amar Sawhney said in prepared remarks. "We look forward to the completion of this trial, and continuing on to the second Phase 3 trial later this year."
The proprietary plugs can be tailored to release their drug payload over a set period of time, after which the material is designed to dissolve.