Phase 3A Single-Center Results Evaluating Sustained-Release Dexamethasone for Treatment of Postoperative Ocular Inflammation and Pain
To evaluate the safety and efficacy of OTX-DP (Ocular Therapeutix) as a sustained release drug (dexamethasone) product placed in the canaliculus of the eyelid for the treatment of ocular inflammation and pain in patients who have undergone cataract surgery.
Immediately following conclusion of the cataract surgery, 38 patients (38 eyes) were randomized (2:1) to receive OTX-DP or a placebo vehicle punctum plug (PV) via insertion in the inferior canaliculus of the operative eye. Patients underwent follow-up at 1, 4, 8, 14, 30 and 60 days post-operatively with primary effectiveness endpoint evaluations for absence of anterior chamber cells at Day 14 and absence of pain at Day 8. In addition, patients were monitored for duration of drug delivery over approximately 30 days. Adverse events for safety were recorded throughout the study.
There are no OTX-DP related serious adverse events noted to date. Final results are pending and will be updated by January 31, 2015.
Based upon previously reported Phase 2 study results, it is anticipated that OTX-DP is safe and effective for the treatment of ocular inflammation and pain in post-cataract patients. As a sustained release drug product, OTX-DP may minimize the risks associated with topical therapy including patient non-compliance and IOP spikes.