Ocular Therapeutix starts Phase 3 clinical program to evaluate safety, efficacy of dexamethasone

Ocular Therapeutix, Inc. announces the start of its Phase 3 clinical program to evaluate the safety and efficacy of their sustained release dexamethasone, an ophthalmic corticosteroid for the treatment of post-operative inflammation and pain following cataract surgery. Ocular Therapeutix's dexamethasone is administered as a one-time, bioabsorbable intracanalicular plug for release of the steroid to the ocular surface for up 30 days.

In the first of two prospective, multicenter, randomized, parallel-arm, double-masked, vehicle-controlled studies, 240 patients undergoing clear corneal cataract surgery will be enrolled at sites throughout the United States. Following surgery, patients will be randomized to either the dexamethasone treatment group or a placebo vehicle plug. Primary endpoints are absence of anterior chamber cells at day 14 and reduction of pain at day 8. "The dexamethasone plug is easily inserted in the operating room immediately following cataract surgery," stated 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."

Physicians routinely prescribe topical steroids post-operatively for the treatment of ocular inflammation and pain. However, patients do not reliably self-administer these drops, which could lead to greater or more persistent inflammation and subsequently affect visual outcomes. Conversely, chronic use of topical steroids can lead to elevations in intraocular pressure, which is a risk factor for glaucoma. "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."