Durezol (difluprednate) - 2 Indications

Scroll down for more information on each indication:

• for the treatment of inflammation and pain associated with ocular surgery; approved June 2008
• for the treatment of endogenous anterior uveitis; approved June of 2012

General Information

Durezol is a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Corticosteroids inhibit the inflammatory response to a variety of inciting agents that may delay or slow healing. They inhibit edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation.

Durezol is specifically indicated for:

•  the treatment of inflammation and pain associated with ocular surgery.
• the treatment of endogenous anterior uveitis.

Mechanism of Action

Durezol is a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Corticosteroids inhibit the inflammatory response to a variety of inciting agents that may delay or slow healing. They inhibit edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotreines by inhibiting the release of their common precursor arachidonic acid.

Side Effects

Adverse events associated with the use of Durezol may include, but are not limited to, the following:

• elevated intraocular pressure
• visual acuity and field defects
• posterior subcapsular cataract formation
• posterior subcapsular cataract formation
• secondary ocular infection from pathogens
• perforation of the globe
• corneal edema
• ciliary and conjunctival hyperemia
• eye pain
• photophobia
• posterior capsule opacification
• anterior chamber flare
• conjunctival edema
• blepharitis

FDA approval of Durezol was based on the results of two clinical trials. These randomized, double-masked, placebo-controlled studies enrolled 327 subjects with an anterior chamber cell grade of less than or equal to 2 (a cell count of 10 or higher) after cataract surgery. The subjects received one drop of Durezol or placebo, self instilled either 2 (BID) or 4 (QID) times per day for 14 days, beginning the day after surgery. The presence of complete clearing (a cell count of 0) was assessed 8 and 15 days post-surgery using a slit lamp binocular microscope. In the intent-to-treat analyses of both studies, a significant benefit was seen in the QID Durezol-treated group in ocular inflammation and reduction of pain when compared with placebo. The results are as follows: Day Eight Anterior Chamber cell clearing was seen in 22% of the Durezol QID arm compared to 7% in the placebo group and reduction of pain was reported in 58% of the Durezol arm and 27% of the placebo arm (p<0.01 for both endpoints). Day Fifteen Anterior Chamber cell clearing was seen in 41% of the Durezol QID arm compared to 11% of the placebo arm and reduction of pain was reported in 63% of the Durezol arm and 35% of the placebo arm (p<0.01 for both endpoints).

Indication 2 - endogenous anterior uveitis

approved June of 2012

Clinical efficacy was evaluated in two randomized, double masked active controlled trials in which patients who presented with endogenous anterior uveitis were treated with either Durezol 4 times daily or prednisolone acetate ophthalmic suspension 1%, 8 times daily for 14 days. Both studies demonstrated that Durezol was equally effective as prednisolone acetate ophthalmic suspension 1% in treating subjects with endogenous anterior uveitis.