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

Objective: To evaluate the efficacy and safety of twice-daily difluprednate ophthalmic emulsion 0.05% (Durezol (R)) 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.