Difluprednate ophthalmic emulsion 0.05% (Durezol®) administered two times daily for managing ocular inflammation and pain following cataract surgery

Abstract

Stephen Smith1, Douglas Lorenz2, James Peace3, Kimberly McLeod4, RS Crockett5, Roger Vogel4, and the Difluprednate ST601-004 Study Group1Eye Associates of Fort Myers, Fort Myers, Florida, USA; 2Nevada Eye and Ear, Henderson, Nevada, USA; 3United Medical Research, Inglewood, California, USA; 4Sirion Therapeutics, Inc., Tampa, Florida, USA; 5DATA, Inc., Bayou La Batre, Alabama, USA. Clinical trial registration number: NCT00616993Objective: To evaluate the efficacy and safety of twice-daily difluprednate ophthalmic ­emulsion 0.05% (Durezol®) versus placebo administered before surgery for managing inflammation and pain following cataract extraction.Methods: Eligible subjects (N = 121) were randomized 2:1 to topical treatment with 1 drop difluprednate or placebo administered twice daily for 16 days, followed by a 14-day ­tapering period. Dosing was initiated 24 hours before unilateral ocular surgery. Clinical signs of ­inflammation (anterior chamber [AC] cell and flare grade, bulbar conjunctival injection, ciliary injection, corneal edema, and chemosis), ocular pain/discomfort, intraocular pressure (IOP), and adverse events were assessed.Results: Clearing of inflammation on day 14 (primary endpoint), defined as an AC cell grade of 0 (≤5 cells) and a flare grade of 0 (complete absence), was achieved in a significantly greater percentage of subjects treated with difluprednate, compared with placebo (74.7% ­vs 42.5%; P = 0.0006). A significantly greater percentage of difluprednate-treated subjects were free of ocular pain/discomfort on day 14 than placebo-treated subjects (64.6% vs 30.0%; P = 0.0004). Three subjects (3.7%) in the difluprednate group had a clinically significant IOP rise (defined as ≥21 mmHg and a change from baseline ≥10 mmHg at same visit).Conclusions: Difluprednate, administered 2 times daily starting 24 hours before cataract ­surgery, was highly effective for managing ocular inflammation and relieving pain and discomfort postoperatively. Difluprednate was well tolerated and provides a convenient twice-daily option for managing postoperative ocular inflammation.Keywords: difluprednate, safety, efficacy, twice daily, postoperative ocular inflammation, corticosteroids