Nepafenac punctal plug significantly reduces postoperative cataract surgery pain
Click Here to Manage Email Alerts
Patients undergoing cataract surgery treated with a nepafenac punctal plug delivery system experienced significantly less postoperative pain compared with those treated with a placebo punctal plug, according to a study.
“The most important finding of the trial is the nepafenac Evolute patients had a significantly higher percentage of pain-free patients than the placebo group. This included 52% of patients in the nepafenac group who were pain-free at all post-surgical visits vs. 0% in the placebo group,” study co-author and OSN Cornea/External Disease Board Member Eric D. Donnenfeld, MD, told Healio/OSN.
Researchers evaluated the safety and efficacy of the Evolute nepafenac punctal plug delivery system (Mati Pharmaceuticals) as part of a pilot phase 2 clinical trial. The prospective, multicenter, randomized, double-masked evaluation included 38 eyes that received the nepafenac punctal plug delivery system (N-PPDS) compared with 18 eyes that received a placebo punctal plug delivery system. All eyes underwent routine unilateral cataract surgery, and researchers evaluated postoperative ocular pain and inflammation.
At 3 days, 69% of patients who received the N-PPDS experienced no ocular pain compared with 38% of patients in the placebo group, a statistically significant difference (P = .038). Overall, 52% of patients in the N-PPDS cohort were pain-free at all postoperative visits compared with 0% in the placebo group (P = .001).
“Postoperative inflammation, as determined by cell and flare scores, also favored the nepafenac Evolute arm. From a clinical perspective, visual acuity was significantly better in the nepafenac arm than the placebo arm,” Donnenfeld said.
The plug retention rate in the overall group was 98.2%, with plug extrusion occurring in one patient in the N-PPDS group before the 1-day postoperative visit. This patient was excluded from the analysis.
The treatment was generally well tolerated with no unexpected side effects reported, Donnenfeld said.
“I feel strongly that the future of medications following cataract surgery is drug delivery that provides low-dose plateaus of therapeutic medications, avoiding the peaks and troughs and the toxicity of preserved topical medications. This trial was the first to investigate a sustained-release use of an NSAID in cataract surgery,” he said.
Perspective
Back to Top
This is an interesting phase 2 study of a novel punctal plug delivery platform for an NSAID, nepafenac, in post-cataract patients. This was a small study with 38 patients in the experimental nepafenac punctal plug delivery system (N-PPDS) group and 18 patients in the placebo punctal plug delivery system (p-PPDS) group. The N-PPDS group had a higher percentage of pain-free patients than that in the p-PPDS group by the day 3 postoperative visit, the 7-day postoperative visit and at all other visits. At the 7-day postoperative visit, there was a significantly higher percent of patients with no anterior chamber cells in the N-PPDS group compared with the p-PPDS group. However, the use of topical Durezol (difluprednate, Novartis) for inflammation was up to the discretion of the treating physician, and there was a non-statistically significantly higher rate of Durezol use of 10.5% in the N-PPDS group compared with 5.6% in the p-PPDS group. Of note, the plug retention rate was 98% at 14 days.
The study was fairly short, at 14 days, and relatively small but provides data that the punctal plug delivery platform is safe and effective at controlling pain after cataract surgery. Further study is needed to assess the impact of the N-PPDS for inflammation after cataract surgery, but this study shows that it may potentially decrease anterior chamber inflammation. Further follow-up in future studies is important to assess for long-term sequelae, including postoperative cystoid macular edema and inflammation.
Collapse
Donnenfeld ED, et al. J Cataract Refract Surg. 2021;doi:10.1097/j.jcrs.0000000000000414.
Read more about
Click Here to Manage Email Alerts