Ocular Therapeutix is beginning two Phase 3 Clinical Trials for OTX-DP, a punctum plug designed for sustained release of dexamethasone to treat post-operative inflammation and pain following cataract surgery. The trials will be conducted in 17 locations, among them will be Texan Eye/Keystone Research, Ltd. in Austin, Texas. In the first study, 240 participants with cataracts will undergo clear corneal cataract surgery and then receive the punctum plug (a resorb able hydrogel drug delivery vehicle) alone or the punctum plug with dexamethasone. At present, the company has begun recruiting in the first of two phase 3 trials.
“The dexamethasone plug is easily inserted in the operating room immediately following cataract surgery,” said Thomas Walters, MD, of Texan Eye in Austin, Texas. “In the earlier Phase 2 clinical trial, it proved effective for relieving pain and inflammation, and patients were comfortable with use of the plug.” For this Phase 3 trial, the primary outcome is the absence of anterior chamber cells 14 days post-surgery, and the secondary outcome evaluates pain in the eye.
Corticosteroids such as dexamethasone are routinely prescribed following ocular surgery to treat inflammation and pain. Usually, patients must self-administer drops, which can result in greater or more persistent inflammation and poor visual outcomes. This is not the case with OTX-DP. “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,” stated Amar Sawhney, Ph.D., President and CEO of Ocular Therapeutix, Inc. “We look forward to the completion of this trial, and continuing on to the second Phase 3 trial later this year.”