FDA approved Durezol (difluprednate) for Ocular Surgery Inflammation and Endogenous Anterior UveitisFDA approved Durezol eye drops for inflammation and pain after eye surgery and uveitis.

Difluprednate is a corticosteroid. The exact mechanism of action in ophthalmic indications is not fully detailed in the label, but corticosteroids are known to inhibit inflammatory responses.

Difluprednate ophthalmic emulsion is indicated for: - Treatment of inflammation and pain associated with ocular surgery. - Treatment of endogenous anterior uveitis.

- For ocular surgery: Instill one drop into the conjunctival sac of the affected eye 4 times daily beginning 24 hours after surgery, continuing throughout the first 2 weeks of the postoperative period, followed by 2 times daily for a week, then taper based on response. - For endogenous anterior uveitis: Instill one drop into the conjunctival sac of the affected eye 4 times daily for 14 days, followed by tapering as clinically indicated. - Initial prescription and renewal beyond one bottle should be made by a physician only after examination with magnification (e.g., slit lamp biomicroscopy) and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after two days, reevaluate the patient. Not more than one bottle should be prescribed initially, and the prescription should not be refilled without further evaluation.

- Ocular Surgery: Two randomized, double-masked, placebo-controlled trials in patients with anterior chamber cell grade ≥2 after cataract surgery. Difluprednate 4 times daily showed significant benefit in clearing anterior chamber cells (cell count = 0) at Days 8 and 15, and reduction of pain at Days 3, 8, and 15 compared with placebo. - Endogenous Anterior Uveitis: Two randomized, double-masked, active-controlled trials comparing difluprednate 4 times daily to prednisolone acetate 1% 8 times daily for 14 days. Both studies demonstrated that difluprednate was equally effective as prednisolone acetate in treating endogenous anterior uveitis, based on mean change from baseline in anterior chamber cell grade.

Contraindicated in most active viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.

Difluprednate ophthalmic emulsion provides a topical corticosteroid option for postoperative ocular inflammation and endogenous anterior uveitis. It may be considered as an alternative to other ophthalmic corticosteroids, with dosing regimens tailored to the indication. As with all corticosteroids, use is contraindicated in certain active infections, and careful monitoring is required.