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

Abstract

Objective: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.

A retrospective analysis of intraocular pressure changes after cataract surgery with the use of prednisolone acetate 1% versus difluprednate 0.05%

“…The choice of corticosteroid is dependent on the physician. For various applications, difluprednate 0.05% has been shown to be more effective in reducing inflammation when compared to PA 1% 2,21–24. However, among all intraocular corticosteroids, studies have reported an increase in IOP with DFBA 23–30.…”

“…Due to the altered structure of DFBA, the synthetic steroid has 56 times increased receptor-binding affinity to glucocorticoid receptors when compared to PA,18 increased anti-inflammatory capacity, and increased tissue penetration 19,20. In ophthalmologic clinical practice, DFBA has been shown to be effective in reducing postoperative inflammation and decreasing corneal edema and retinal thickness 2,21–24. However, reports have shown an increase in IOP when used after ophthalmologic surgery 23–29…”

“…While studies have compared DFBA versus PA for vitreoretinal surgery28,29 and anterior uveitis,21,30 few have investigated IOP increase with the use of these drugs in the context of cataract surgery 2,24. Here, the results of a large (n=4,184) retrospective study evaluating the potential for corticosteroid-induced ocular hypertension with the use of either PA (n=2,151) or DFBA (n=1,337) in post-cataract surgery patients are reported.…”

Steroid-Induced Iatrogenic Glaucoma

“…Elevated IOP was effectively controlled with topical medication. In another randomized trial on 182 patients, 3 subjects (3.7%) in the difluprednate group had a clinically significant IOP rise ( 6 10 mm Hg from baseline and 6 21 mm Hg overall) compared to the placebo group [81] . Long-term steroid creams, lotions and ointments applied to the face, eyelids, or at distant sites may raise the IOP, as so may systemically administered corticosteroids [27, 34,46,[82][83][84] .…”

“…This results in increased deposition of glycosaminoglycan, elastin, fibronectin, laminin, and type IV collagen as part of the extracellular matrix secondary to increased production and decreased destruction because of inhibition of several trabecular meshwork matrix metalloproteinases [81][82][83] . Additionally, dexamethasone is known to inhibit the phagocytic abilities of trabecular meshwork cells so that debris accumulates within the drainage channels [113] .…”