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Corticosteroid punctum plug reduces inflammation, pain after cataract surgery
The sustained-release plug performed better than a placebo plug in reducing inflammatory cells and pain in a phase 2 clinical trial.
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A corticosteroid-loaded punctum plug significantly reduced inflammation and pain after cataract surgery, according to results of a phase 2 clinical trial.
The hydrogel plug (dexamethasone, Ocular Therapeutix) showed promising results, one investigator said.
This is the first time in ophthalmology that a punctal plug has been used to deliver a pharmaceutical for control of pain and inflammation during cataract surgery, Thomas R. Walters, MD, told Ocular Surgery News.
The hydrogel plug delivers a 4-week tapered dose. After treatment is complete, the hydrogel is absorbed and exits the nasolacrimal system without surgical removal.
“It’s very elegant because it doesn’t require any flushing. It doesn’t require anything other than its placement. As a standalone agent, it was able to control both pain and inflammation,” Walters said.
He said that the sustained-release plug eliminates the need for patients to self-administer eye drops.
Study details
The prospective, multicenter, randomized, controlled phase 2 clinical trial included 59 patients older than 21 years who underwent cataract surgery. The trial began in October 2012 and was completed in August 2013.
Twenty-nine patients received the dexamethasone punctum plug, and 30 patients received a placebo plug.
Primary outcome measures were absence of cells in the anterior chamber and absence of pain at 8 days. Secondary outcome measures were absence of cells in the anterior chamber and absence of pain at multiple time points up to 30 days.
Final follow-up was at 30 days. Subsequently, patients were followed every 15 days until the plug was no longer present.
“The punctal plug maintained a continuous, sustained release of the dexamethasone product,” Walters said.
Absence of cells
The dexamethasone plug was superior to placebo in the absence of anterior chamber cells at 14 days and 30 days (P < .005).
“By absence of anterior chamber cells, we mean zero cells, which is not typical for studies like this. Zero cells was a very high bar to cover. So, it controlled statistically significantly better than placebo,” Walters said.
Mean pain score was 0.6 in the dexamethasone plug group compared with 2 in the placebo group, according to Walters.
The dexamethasone plug was statistically superior to placebo for absence of pain at all time points (P < .005), he said.
No adverse events related to the dexamethasone plug were reported. In addition, no long-term IOP spikes were reported in either group, Walters said.
“The plugs have been tolerated extremely well by the canalicular system, which is largely to be expected because this product is carrying an anti-inflammatory, which is dexamethasone,” he said.
Significantly more patients in the placebo group were given postoperative anti-inflammatory medications compared with patients who received the dexamethasone plug.
A phase 3 trial of the plug began in February 2014 and is scheduled to end in February 2015. A second trial began in April 2014 and is scheduled to end in March 2015.
Current enrollment for both phase 3 trials is 240 patients.
The primary outcome measure for both trials is absence of inflammatory cells in the anterior chamber; the secondary outcome measure is the presence of cells in the anterior chamber. – by Matt Hasson
References:
Phase II study evaluating safety/efficacy of OTX-DP for treatment of ocular inflammation and pain after cataract surgery. ClinicalTrials.gov. clinicaltrials.gov/show/NCT01666210. Updated Nov. 19, 2013.Phase 3 study evaluating safety and efficacy of OTX-DP for treatment of ocular inflammation and pain after cataract surgery. ClinicalTrials.gov. clinicaltrials.gov/show/NCT02034019. Updated Oct. 8, 2014.
Second phase 3 study evaluating safety and efficacy of OTX-DP for treatment of ocular inflammation and pain after cataract surgery. ClinicalTrials.gov. clinicaltrials.gov/show/NCT02089113. Updated Oct. 8, 2014.
For more information:
Thomas R. Walters, MD, can be reached at Texan Eye, 5717 Balcones Drive, Austin, TX 78731; 512-327-7000; email: tom@nobhill.me.Disclosure: Walters has received travel support from Ocular Therapeutix.