A recent clinical phase II trial found nepafenac punctal plug drug delivery system (PPDS) to be safe and effective for reducing pain and inflammation associated with cataract surgery.
Compared with placebo-treated controls, patients receiving the nepafenac PPDS also experienced fewer adverse events and superior visual acuity outcomes, study lead Professor Eric Donnenfeld told Ophthalmology Times.
“The nepafenac PPDS simplifies medical management for the elderly patient population and resolves the problems associated with the use of topical medication. It demonstrated unprecedented efficacy in reducing pain and inflammation after cataract surgery in the phase II study.” Provided that outcomes are confirmed in phase III trials, the nepafenac PPDS may replace topical nonsteroidal anti-inflammatory drops in cataract surgery, he said.
The multi-centre, randomised, masked trial evaluated nepafenac PPDS vs. placebo in 56 patients undergoing cataract surgery. Nepafenac PPDS demonstrated a statistically significant difference compared to placebo for pain scores at day three following surgery, 70% of patients treated with nepafenac experienced no pain versus 38% in the placebo arm (p= 0.0032). 42% of patients using nepafenac PPDS were pain-free throughout the trial period versus 0% for placebo.
Nepafenac PPDS also demonstrated a statistically significant difference for post-operative inflammation, as determined by cell and flare scores, for subjects with none-to-mild anterior chamber cells at day three. No adverse effects were reported.
The effective control of pain and inflammation with nepafenac PPDS following cataract surgery resulted in improved clinical outcomes, confirmed by day-14 best corrected and uncorrected visual acuity scores. The percentage of subjects with 20/20 or better corrected visual acuity was 65% for subjects treated with nepafenac PPDS, versus 29% for those treated with placebo. The percentage of subjects with an uncorrected visual acuity of 20/25 or better was 53% for nepafenac PPDS versus 14% for placebo.
