Dexamethasone punctum plug reduces inflammation, pain
CHICAGO — A tapered-release dexamethasone punctum plug was superior to a placebo punctum plug in clearing anterior chamber cells and reducing pain after cataract surgery, a speaker said here.
“The sustained release of dexamethasone in punctal plugs minimizes postoperative inflammation and pain while reducing the patients’ burden of dosing themselves,” Thomas R. Walters, MD, said at the American Academy of Ophthalmology meeting.
The prospective, multicenter, randomized phase 2 study included 60 patients who underwent cataract surgery; 30 patients received a sustained-release dexamethasone-eluting punctum plug (Ocular Therapeutix) 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.
The dexamethasone plug was statistically superior to placebo in clearing anterior chamber cells at 14 days and 30 days, according to Walters.
Additionally, significantly more placebo patients were given postoperative anti-inflammatory medications compared with patients who received the dexamethasone plug.
Mean pain scores were 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, 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.
Phase 3 studies are ongoing.
Disclosure: Walters has received travel support from Ocular Therapeutix.