Ocular Therapeutix Completes Enrollment In Phase 3 Sustained Release Dexamethasone Trials For Post-Operative Inflammation And Pain

Ocular Therapeutix, Inc. OCUL announced today completion of enrollment for its two Phase 3 clinical trials evaluating Sustained Release Dexamethasone (OTX-DP) for treatment of ocular inflammation and pain following cataract surgery. OTX-DP is a one-time administration product candidate placed in the canaliculus and designed to deliver dexamethasone to the ocular surface for approximately four weeks. Following treatment, OTX-DP resorbs and exits the nasolacrimal system without the need for removal. The two prospective, multicenter, randomized, parallel-arm, double-masked, vehicle-controlled studies are evaluating 486 patients at 32 sites throughout the United States. Following surgery, patients were randomized to receive either OTX-DP or a placebo vehicle punctum plug without active drug. Primary efficacy endpoints for the studies are the absence of inflammatory cells in the anterior chamber of the eye at Day 14, and reduction of pain at Day 8. “Completion of enrollment for OTX-DP is an extraordinary milestone for our company, not only as our first Phase 3 clinical trials for a sustained release pharmaceutical, but also the first Phase 3 trials ever to be completed for a sustained release, drug delivery punctum plug,” stated Amar Sawhney, Ph.D., President and CEO of Ocular Therapeutix, Inc. “We look forward to submitting results to the FDA in 2015.” Topical corticosteroids are typically prescribed to treat ocular inflammation and pain following ophthalmic surgery. However, topical steroid regimens can be complex, which can lead to lower levels of compliance and thus may adversely affect outcomes. Conversely, chronic administration of topical corticosteroids can lead to spikes in intraocular pressure, which may induce glaucoma. A physician administered, single-dose corticosteroid puts compliance in the hands of physicians, and may improve issues of patient non-compliance with dosing regimens. “OTX-DP is easily inserted, and can be monitored by the physician during the post-operative period,” stated Thomas R. Walters, M.D., Principal Investigator at Texan Eye in Austin, Texas. “In a previously completed Phase 2 clinical trial, treatment with OTX-DP significantly relieved pain at Day 8, as reported by the patient, and inflammation at Day 14, as measured by absence of inflammatory cells in the anterior chamber of the eye, compared to vehicle control, and patients were comfortable with the plug.”