Evaluation of Safety and Efficacy of Sustained Release Dexamethasone After Cataract Surgery for Treatment of Postoperative Inflammation and Pain: Multicenter Phase 3A Study
To evaluate the safety and efficacy of OTX-DP (Ocular Therapeutix) as a sustained release drug (dexamethasone) product when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in patients who have undergone cataract extraction with intra-ocular lens implantation.
This study of 246 cataract patients (246 eyes) were treated across 16 sites in a prospective registration study. Immediately following conclusion of the cataract surgery, based on a 2:1 randomization, OTX-DP or the placebo vehicle punctum plug (PV) was inserted in the vertical canaliculus of the operative eye. Patients underwent follow-up at post-operative days 1, 4, 8, 14, 30, and 60 and were evaluated for absence of anterior chamber cells at Day 14 and absence of pain at Day 8. In addition, patients were monitored for retention of the punctum plug and adverse events throughout the study.
No serious adverse events related to OTX-DP have been reported to date. Final results are pending.
It is anticipated that OTX-DP is safe and effective for the treatment of ocular inflammation and pain in post-cataract patients. The sustained released drug product is a potential means to overcome patient compliance to topical therapy and minimize post-operative complications including long term IOP spikes.