Single-Center Results of Safety and Efficacy Evaluation of Sustained-Release Dexamethasone After Cataract Surgery
Narrative Responses:
Purpose
To evaluate the safety and efficacy of OTX-DP (Ocular Therapeutix, Inc.) as a sustained release drug (dexamethasone) product placed in the canaliculus of the eyelid for the treatment of ocular inflammation and pain in subjects who have undergone cataract surgery.
Methods
Immediately following cataract surgery, 30 subjects (30 eyes) were randomized to receive OTX-DP or a placebo vehicle punctum plug (PVPP) via insertion in the inferior vertical canaliculus of the operative eye. Subjects underwent follow-up at 1, 4, 8, 11, 14, and 30 days postoperatively. If the punctum plug was still visible in the canaliculus at Day 30, follow-up continued every 15 days until the punctum plug was no longer present.
Results
33% and 47% of OTX-DP patients had zero anterior chamber cells at Days 8 and 14, respectively, versus 0.0% for the placebo group at the same time points. Similarly, a significantly higher percentage of subjects in the OTX-DP group (87% and 73%) than in the PVPP group (27% and 27%) presented with an absence of pain at Days 8 and 14, respectively. OTX-DP was retained in 100% of cases through Day 30. There were no OTX-DP related adverse events noted during the trial, and no IOP exceeded 23 mmHg in OTX-DP treated subjects.
Conclusion
OTX-DP was shown to be more effective than placebo at clearing anterior chamber cells and reducing pain at Days 8 and 14, with fewer OTX-DP subjects requiring rescue medications. OTX-DP was shown to be safe, exhibiting the benefits associated with a topical steroid without the risk of IOP spikes.