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Difluprednate ophthalmic emulsion is a corticosteroid indicated for: • The treatment of inflammation and pain associated with ocular surgery. ( 1.1 ) • The treatment of endogenous anterior uveitis. ( 1.2 ) 1.1 Ocular Surgery Difluprednate ophthalmic emulsion is indicated for the treatment of inflammation and pain associated with ocular surgery. 1.2 Endogenous Anterior Uveitis Difluprednate ophthalmic emulsion is indicated for the treatment of endogenous anterior uveitis.

Difluprednate ophthalmic emulsion, as with other ophthalmic corticosteroids, is 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 disease of ocular structures. Difluprednate ophthalmic emulsion is 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. ( 4 )

• Intraocular Pressure (IOP) Increase: Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. If difluprednate ophthalmic emulsion is used for 10 days or longer, IOP should be monitored. ( 5.1 ) • Cataracts: Use of corticosteroids may result in posterior subcapsular cataract formation. ( 5.2 ) • Delayed Healing: The use of corticosteroids after cataract surgery may delay healing and increase the incidence of bleb formation. ( 5.3 ) • Corneal and Scleral Melting: In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids. ( 5.4 ) • Bacterial Infections: Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, corticosteroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be reevaluated. ( 5.5 ) • Viral Infections: Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). ( 5.6 ) • Fungal Infections: Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid application. Fungus …

8.1 Pregnancy Risk Summary There are no available data on difluprednate ophthalmic emulsion use in pregnant women to evaluate for a drug- associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Systemic exposure to difluprednate ophthalmic emulsion following ocular administration is low [see Clinical Pharmacology ( 12.3 )]. Consequently, the systemic exposure of a pregnant woman to difluprednate is expected to be minimal following topical ocular administration. In animal reproductive studies, subcutaneous administration of difluprednate to pregnant rabbits and rats throughout organogenesis produced maternal toxicity, embryo-fetal toxicity and …