Multi-Center Evaluation of Safety and Efficacy of Sustained-Release Dexamethasone After Cataract Surgery
Narrative Responses:
Purpose
To evaluate the safety and efficacy of OTX-DP (Ocular Therapeutix, Inc.), a two-week sustained release dexamethasone with a two-week taper, inserted as a punctum plug in the canaliculus of the eyelid for the treatment of ocular inflammation and pain in subjects who have undergone cataract extraction with intraocular lens implantation
Methods
Sixty cataract patients were randomized across 4 sites in a prospective clinical study. Immediately following cataract surgery, OTX-DP or a placebo vehicle punctum plug (PVPP) was inserted in the inferior vertical canaliculus of the operative eye. Subjects underwent follow-up at postoperative Days 1, 4, 8, 11, 14, and 30. If the punctum plug was retained in the canaliculus at Day 30, follow-up continued every 15 days until the investigator confirmed that it was no longer present. Subjects were then exited from the study
Results
34.5% of OTX-DP subjects (n=29) versus 3.4% of PVPP subjects (n=30) at Day 14 (p=0.0027) and 62.1% versus 13.8% at Day 30 (p=0.0002) had an absence of anterior chamber cells. Additionally, 44.8% to 59.4% more OTX-DP treated subjects had an absence of pain at Days 1, 4, 8, 11, 14, and 30 compared to the PVPP group (p≤0.0002). OTX-DP was retained in 100% of cases through Day 14 and 97% through Day 30. 21% of OTX-DP subjects were administered rescue medications compared to 77% of PVPP subjects. Investigators noted no long-term IOP spikes and no adverse events related to OTX-DP.
Conclusion
OTX-DP was statistically significantly superior to PVPP for clearing anterior chamber cells at Day 14 and Day 30 and for reducing pain at all follow-up visits. The retention and safety of OTX-DP was established in this study, including the abscence of long-term IOP spikes associated with topical steroid use.