{"id":"difluprednate","rwe":[{"pmid":"41749599","year":"2026","title":"Drugs Associated with Pediatric Cataracts: A Real-World Pharmacovigilance Study.","finding":"","journal":"Children (Basel, Switzerland)","studyType":"Clinical Study"},{"pmid":"41322442","year":"2025","title":"Optical Coherence Tomography (OCT) Biomarkers for Nonsurgical Management of Postvitrectomy Secondary Macular Holes With Intravitreal Triamcinolone Acetonide (1 mg/0.1 mL): A Case Report of Two Cases.","finding":"","journal":"Case reports in ophthalmological medicine","studyType":"Clinical Study"},{"pmid":"41022198","year":"2025","title":"Uveitis associated with immunotherapy and its response to monotherapy with difluprednate: A case report.","finding":"","journal":"Archivos de la Sociedad Espanola de Oftalmologia","studyType":"Clinical Study"},{"pmid":"40987220","year":"2025","title":"A case report on acute cystoid macular edema days after YAG laser capsulotomy.","finding":"","journal":"International journal of surgery case reports","studyType":"Clinical Study"},{"pmid":"40861322","year":"2025","title":"A Retrospective Data Analysis of Patients Treated with Difluprednate and Bromfenac for Cystoid Macular Edema After Uveitis or Cataract Surgery.","finding":"","journal":"Clinical ophthalmology (Auckland, N.Z.)","studyType":"Clinical Study"}],"_fda":{"id":"3dd0b742-d0d7-4922-8c9d-01293432b710","set_id":"054ca798-454a-41cc-9d08-97bb8bef5620","openfda":{"upc":["0369315329054"],"unii":["S8A06QG2QE"],"route":["OPHTHALMIC"],"rxcui":["804544"],"spl_id":["3dd0b742-d0d7-4922-8c9d-01293432b710"],"brand_name":["DIFLUPREDNATE"],"spl_set_id":["054ca798-454a-41cc-9d08-97bb8bef5620"],"package_ndc":["69315-329-05"],"product_ndc":["69315-329"],"generic_name":["DIFLUPREDNATE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["DIFLUPREDNATE"],"manufacturer_name":["Leading Pharma, LLC"],"application_number":["ANDA219441"],"is_original_packager":[true]},"version":"1","pregnancy":["8.1 Pregnancy Pregnancy Category C. Difluprednate has been shown to be embryotoxic (decrease in embryonic body weight and a delay in embryonic ossification) and teratogenic (cleft palate and skeletal anomalies) when administered subcutaneously to rabbits during organogenesis at a dose of 1-10 mcg/kg/day. The no-observed-effect-level (NOEL) for these effects was 1 mcg/kg/day, and 10 mcg/kg/day was considered to be a teratogenic dose that was concurrently found in the toxic dose range for fetuses and pregnant females. Treatment of rats with 10 mcg/kg/day subcutaneously during organogenesis did not result in any reproductive toxicity, nor was it maternally toxic. At 100 mcg/kg/day after subcutaneous administration in rats, there was a decrease in fetal weights and delay in ossification, and effects on weight gain in the pregnant females. It is difficult to extrapolate these doses of difluprednate to maximum daily human doses of difluprednate ophthalmic emulsion, since difluprednate ophthalmic emulsion is administered topically with minimal systemic absorption, and difluprednate blood levels were not measured in the reproductive animal studies. However, since use of difluprednate during human pregnancy has not been evaluated and cannot rule out the possibility of harm, difluprednate ophthalmic emulsion should be used during pregnancy only if the potential benefit justifies the potential risk to the embryo or fetus."],"description":["11 DESCRIPTION Difluprednate ophthalmic emulsion 0.05% is a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. The chemical name is 6α, 9difluoro-11 β ,17,21-trihydroxypregna-1,4-diene-3,20-dione 21-acetate 17-butyrate (CAS number 23674-86-4). Difluprednate is represented by the following structural formula: Difluprednate has a molecular weight of 508.56, and the molecular formula is C 27 H 34 F 2 O 7 . Each mL contains: ACTIVE: difluprednate 0.5 mg (0.05%); INACTIVE: boric acid, castor oil, glycerin, polysorbate 80, water for injection, sodium acetate, edetate disodium, sodium hydroxide (to adjust the pH to 5.2 to 5.8). The emulsion is essentially isotonic with a tonicity of 304 to 411 mOsm/kg. PRESERVATIVE: sorbic acid 0.1%. chemicalstructure"],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING Difluprednate ophthalmic emulsion 0.05% is a sterile, aqueous topical ophthalmic emulsion supplied in an opaque plastic bottle with a controlled drop tip and a pink cap in the following sizes: 5 mL in a 5 mL bottle NDC 69315-329-05 Storage and Handling Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light. When not in use, keep the bottles in the protective carton."],"geriatric_use":["8.5 Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients."],"pediatric_use":["8.4 Pediatric Use Difluprednate ophthalmic emulsion was evaluated in a 3-month multicenter, double-masked trial in 79 pediatric patients (39 difluprednate; 40 prednisolone acetate) 0 to 3 years of age for the treatment of inflammation following cataract surgery. A similar safety profile was observed in pediatric patients comparing difluprednate ophthalmic emulsion to prednisolone acetate ophthalmic suspension, 1%."],"effective_time":"20250208","nursing_mothers":["8.3 Nursing Mothers It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when difluprednate ophthalmic emulsion is administered to a nursing woman."],"clinical_studies":["14 CLINICAL STUDIES 14.1 Ocular Surgery Clinical efficacy was evaluated in 2 randomized, double-masked, placebo-controlled trials in which subjects with an anterior chamber cell grade ≥ “2” (a cell count of 11 or higher) after cataract surgery were assigned to difluprednate ophthalmic emulsion or placebo (vehicle) following surgery. One drop of difluprednate ophthalmic emulsion or vehicle was self-instilled either 2 times per day or 4 times per day for 14 days, beginning the day after surgery. The presence of complete clearing (a cell count of 0) was assessed 3, 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 4 times per day (QID) difluprednate ophthalmic emulsion-treated group in ocular inflammation, at Days 8 and 15, and reduction of pain, at Days 3, 8, and 15, when compared with placebo. The consolidated clinical trial results are provided below. fig1 fig2 14.2 Endogenous Anterior Uveitis 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 difluprednate ophthalmic emulsion 4 times daily or prednisolone acetate ophthalmic suspension, 1%, 8 times daily for 14 days. Both studies demonstrated that difluprednate ophthalmic emulsion was equally effective as prednisolone acetate ophthalmic suspension, 1% in treating subjects with endogenous anterior uveitis. Mean Change from Baseline in Anterior Chamber Cell Grade With 5 grades: 0 = 0 cells; 1 = 1 to 10 cells; 2 = 11 to 20 cells; 3 = 21 to 50 cells; and 4 = >50 cells. Study 1 Time Point Difluprednate Ophthalmic Emulsion N = 57 Prednisolone Acetate N = 53 Difference Adjusted for baseline AC cell grade and study center and based on ITT dataset with LOCF for missing data. (95% CI) Baseline 2.6 2.5 0.0 (-0.22, 0.28) Day 3 -1.0 -1.0 -0.1 (-0.35, 0.25) Day 7 -1.6 -1.5 -0.0 (-0.31, 0.25) Day 14 -2.0 -1.8 -0.2 (-0.46, 0.10) Day 21 -2.2 -1.9 -0.3 (-0.53, 0.01) Day 28 -2.2 -2.1 -0.1 (-0.37, 0.18) Day 35 -2.1 -2.0 -0.1 (-0.39, 0.20) Day 42 -2.1 -2.1 0.0 (-0.27, 0.34) Study 2 Time Point Difluprednate Ophthalmic Emulsion N = 50 Prednisolone Acetate N = 40 Difference (95% CI) Baseline 2.4 2.4 0.0 (-0.21, 0.29) Day 3 -0.9 -0.9 -0.0 (-0.34, 0.25) Day 7 -1.7 -1.6 -0.1 (-0.35, 0.21) Day 14 -1.9 -1.8 -0.1 (-0.34, 0.20) Day 21 -2.0 -2.0 0.0 (-0.25, 0.28) Day 28 -2.0 -2.0 0.0 (-0.21, 0.26) Day 35 -2.1 -2.0 -0.1 (-0.32, 0.16) Day 42 -2.0 -1.9 -0.1 (-0.36, 0.24)","14.1 Ocular Surgery Clinical efficacy was evaluated in 2 randomized, double-masked, placebo-controlled trials in which subjects with an anterior chamber cell grade ≥ “2” (a cell count of 11 or higher) after cataract surgery were assigned to difluprednate ophthalmic emulsion or placebo (vehicle) following surgery. One drop of difluprednate ophthalmic emulsion or vehicle was self-instilled either 2 times per day or 4 times per day for 14 days, beginning the day after surgery. The presence of complete clearing (a cell count of 0) was assessed 3, 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 4 times per day (QID) difluprednate ophthalmic emulsion-treated group in ocular inflammation, at Days 8 and 15, and reduction of pain, at Days 3, 8, and 15, when compared with placebo. The consolidated clinical trial results are provided below. fig1 fig2","14.2 Endogenous Anterior Uveitis 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 difluprednate ophthalmic emulsion 4 times daily or prednisolone acetate ophthalmic suspension, 1%, 8 times daily for 14 days. Both studies demonstrated that difluprednate ophthalmic emulsion was equally effective as prednisolone acetate ophthalmic suspension, 1% in treating subjects with endogenous anterior uveitis. Mean Change from Baseline in Anterior Chamber Cell Grade With 5 grades: 0 = 0 cells; 1 = 1 to 10 cells; 2 = 11 to 20 cells; 3 = 21 to 50 cells; and 4 = >50 cells. Study 1 Time Point Difluprednate Ophthalmic Emulsion N = 57 Prednisolone Acetate N = 53 Difference Adjusted for baseline AC cell grade and study center and based on ITT dataset with LOCF for missing data. (95% CI) Baseline 2.6 2.5 0.0 (-0.22, 0.28) Day 3 -1.0 -1.0 -0.1 (-0.35, 0.25) Day 7 -1.6 -1.5 -0.0 (-0.31, 0.25) Day 14 -2.0 -1.8 -0.2 (-0.46, 0.10) Day 21 -2.2 -1.9 -0.3 (-0.53, 0.01) Day 28 -2.2 -2.1 -0.1 (-0.37, 0.18) Day 35 -2.1 -2.0 -0.1 (-0.39, 0.20) Day 42 -2.1 -2.1 0.0 (-0.27, 0.34) Study 2 Time Point Difluprednate Ophthalmic Emulsion N = 50 Prednisolone Acetate N = 40 Difference (95% CI) Baseline 2.4 2.4 0.0 (-0.21, 0.29) Day 3 -0.9 -0.9 -0.0 (-0.34, 0.25) Day 7 -1.7 -1.6 -0.1 (-0.35, 0.21) Day 14 -1.9 -1.8 -0.1 (-0.34, 0.20) Day 21 -2.0 -2.0 0.0 (-0.25, 0.28) Day 28 -2.0 -2.0 0.0 (-0.21, 0.26) Day 35 -2.1 -2.0 -0.1 (-0.32, 0.16) Day 42 -2.0 -1.9 -0.1 (-0.36, 0.24)"],"pharmacokinetics":["12.3 Pharmacokinetics Difluprednate undergoes deacetylation in vivo to 6α, 9-difluoroprednisolone 17-butyrate (DFB), an active metabolite of difluprednate. Clinical pharmacokinetic studies of difluprednate after repeat ocular instillation of 2 drops of difluprednate (0.01% or 0.05%) 4 times per day for 7 days showed that DFB levels in blood were below the quantification limit (50 ng/mL) at all time points for all subjects, indicating the systemic absorption of difluprednate after ocular instillation of difluprednate ophthalmic emulsion is limited."],"adverse_reactions":["6 ADVERSE REACTIONS The following serious reactions are found elsewhere in the labeling: Elevated intraocular pressure [see Warnings and Precautions (5.1) ] Posterior subcapsular cataract formation [see Warnings and Precautions (5.2) ] Secondary ocular infection [see Warnings and Precautions (5.4) ] Perforation of the globe [see Warnings and Precautions (5.3) ] 6.1 Ocular Surgery Ocular adverse reactions occurring in 5-15% of subjects in clinical studies with difluprednate ophthalmic emulsion included corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacification, anterior chamber cells, anterior chamber flare, conjunctival edema, and blepharitis. Other ocular adverse reactions occurring in 1-5% of subjects included reduced visual acuity, punctate keratitis, eye inflammation, and iritis. Ocular adverse reactions occurring in < 1% of subjects included application site discomfort or irritation, corneal pigmentation and striae, episcleritis, eye pruritis, eyelid irritation and crusting, foreign body sensation, increased lacrimation, macular edema, sclera hyperemia, and uveitis. Most of these reactions may have been the consequence of the surgical procedure. 6.2 Endogenous Anterior Uveitis A total of 200 subjects participated in the clinical trials for endogenous anterior uveitis, of which 106 were exposed to difluprednate ophthalmic emulsion. The most common adverse reactions of those exposed to difluprednate ophthalmic emulsion occurring in 5-10% of subjects included blurred vision, eye irritation, eye pain, headache, increased IOP, iritis, limbal and conjunctival hyperemia, punctate keratitis, and uveitis. Adverse reactions occurring in 2-5% of subjects included anterior chamber flare, corneal edema, dry eye, iridocyclitis, photophobia, and reduced visual acuity.","6.1 Ocular Surgery Ocular adverse reactions occurring in 5-15% of subjects in clinical studies with difluprednate ophthalmic emulsion included corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacification, anterior chamber cells, anterior chamber flare, conjunctival edema, and blepharitis. Other ocular adverse reactions occurring in 1-5% of subjects included reduced visual acuity, punctate keratitis, eye inflammation, and iritis. Ocular adverse reactions occurring in < 1% of subjects included application site discomfort or irritation, corneal pigmentation and striae, episcleritis, eye pruritis, eyelid irritation and crusting, foreign body sensation, increased lacrimation, macular edema, sclera hyperemia, and uveitis. Most of these reactions may have been the consequence of the surgical procedure.","6.2 Endogenous Anterior Uveitis A total of 200 subjects participated in the clinical trials for endogenous anterior uveitis, of which 106 were exposed to difluprednate ophthalmic emulsion. The most common adverse reactions of those exposed to difluprednate ophthalmic emulsion occurring in 5-10% of subjects included blurred vision, eye irritation, eye pain, headache, increased IOP, iritis, limbal and conjunctival hyperemia, punctate keratitis, and uveitis. Adverse reactions occurring in 2-5% of subjects included anterior chamber flare, corneal edema, dry eye, iridocyclitis, photophobia, and reduced visual acuity."],"contraindications":["4 CONTRAINDICATIONS The use of 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, 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 diseases of ocular structures. (4)"],"mechanism_of_action":["12.1 Mechanism of Action Corticosteroids inhibit the inflammatory response to a variety of inciting agents and 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. Arachidonic acid is released from membrane phospholipids by phospholipase A2. Difluprednate is structurally similar to other corticosteroids."],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Corticosteroids inhibit the inflammatory response to a variety of inciting agents and 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. Arachidonic acid is released from membrane phospholipids by phospholipase A2. Difluprednate is structurally similar to other corticosteroids. 12.3 Pharmacokinetics Difluprednate undergoes deacetylation in vivo to 6α, 9-difluoroprednisolone 17-butyrate (DFB), an active metabolite of difluprednate. Clinical pharmacokinetic studies of difluprednate after repeat ocular instillation of 2 drops of difluprednate (0.01% or 0.05%) 4 times per day for 7 days showed that DFB levels in blood were below the quantification limit (50 ng/mL) at all time points for all subjects, indicating the systemic absorption of difluprednate after ocular instillation of difluprednate ophthalmic emulsion is limited."],"indications_and_usage":["1 INDICATIONS AND USAGE Difluprednate ophthalmic emulsion is a topical corticosteroid that is 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 0.05%, a topical corticosteroid, is indicated for the treatment of inflammation and pain associated with ocular surgery. 1.2 Endogenous Anterior Uveitis Difluprednate ophthalmic emulsion is also indicated for the treatment of endogenous anterior uveitis.","1.1 Ocular Surgery Difluprednate ophthalmic emulsion 0.05%, a topical corticosteroid, is indicated for the treatment of inflammation and pain associated with ocular surgery.","1.2 Endogenous Anterior Uveitis Difluprednate ophthalmic emulsion is also indicated for the treatment of endogenous anterior uveitis."],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS 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 this product 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 steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order beyond 28 days should be made by a physician only after examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. (5.3) Bacterial infections- Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated. (5.4) Viral infections- Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). (5.5) Fungal infections- Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. (5.6) To report SUSPECTED ADVERSE REACTIONS, contact LEADING PHARMA,LLC AT 1-844-740-7500,or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 5.1 IOP Increase Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. If this product is used for 10 days or longer, intraocular pressure should be monitored. 5.2 Cataracts Use of corticosteroids may result in posterior subcapsular cataract formation. 5.3 Delayed Healing The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order beyond 28 days should be made by a physician only after examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. 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, steroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated. 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 steroids 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 steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate. 5.7 Topical Ophthalmic Use Only Difluprednate ophthalmic emulsion is not indicated for intraocular administration. 5.8 Contact Lens Wear Difluprednate ophthalmic emulsion should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of difluprednate ophthalmic emulsion. The preservative in difluprednate ophthalmic emulsion may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of difluprednate ophthalmic emulsion.","5.1 IOP Increase Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. If this product is used for 10 days or longer, intraocular pressure should be monitored.","5.2 Cataracts Use of corticosteroids may result in posterior subcapsular cataract formation.","5.3 Delayed Healing The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order beyond 28 days should be made by a physician only after examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.","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, steroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.","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 steroids 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 steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate.","5.7 Topical Ophthalmic Use Only Difluprednate ophthalmic emulsion is not indicated for intraocular administration.","5.8 Contact Lens Wear Difluprednate ophthalmic emulsion should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of difluprednate ophthalmic emulsion. The preservative in difluprednate ophthalmic emulsion may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of difluprednate ophthalmic emulsion."],"clinical_studies_table":["
Mean Change from Baseline in Anterior Chamber Cell GradeWith 5 grades: 0 = 0 cells; 1 = 1 to 10 cells; 2 = 11 to 20 cells; 3 = 21 to 50 cells; and 4 = >50 cells.
Study 1Time PointDifluprednate Ophthalmic EmulsionN = 57Prednisolone AcetateN = 53DifferenceAdjusted for baseline AC cell grade and study center and based on ITT dataset with LOCF for missing data.(95% CI)
Baseline2.62.50.0 (-0.22, 0.28)
Day 3-1.0-1.0-0.1 (-0.35, 0.25)
Day 7-1.6-1.5-0.0 (-0.31, 0.25)
Day 14-2.0-1.8-0.2 (-0.46, 0.10)
Day 21-2.2-1.9-0.3 (-0.53, 0.01)
Day 28-2.2-2.1-0.1 (-0.37, 0.18)
Day 35-2.1-2.0-0.1 (-0.39, 0.20)
Day 42-2.1-2.10.0 (-0.27, 0.34)
Study 2Time PointDifluprednate Ophthalmic EmulsionN = 50Prednisolone AcetateN = 40Difference(95% CI)
Baseline2.42.40.0 (-0.21, 0.29)
Day 3-0.9-0.9-0.0 (-0.34, 0.25)
Day 7-1.7-1.6-0.1 (-0.35, 0.21)
Day 14-1.9-1.8-0.1 (-0.34, 0.20)
Day 21-2.0-2.00.0 (-0.25, 0.28)
Day 28-2.0-2.00.0 (-0.21, 0.26)
Day 35-2.1-2.0-0.1 (-0.32, 0.16)
Day 42-2.0-1.9-0.1 (-0.36, 0.24)
","
Mean Change from Baseline in Anterior Chamber Cell GradeWith 5 grades: 0 = 0 cells; 1 = 1 to 10 cells; 2 = 11 to 20 cells; 3 = 21 to 50 cells; and 4 = >50 cells.
Study 1Time PointDifluprednate Ophthalmic EmulsionN = 57Prednisolone AcetateN = 53DifferenceAdjusted for baseline AC cell grade and study center and based on ITT dataset with LOCF for missing data.(95% CI)
Baseline2.62.50.0 (-0.22, 0.28)
Day 3-1.0-1.0-0.1 (-0.35, 0.25)
Day 7-1.6-1.5-0.0 (-0.31, 0.25)
Day 14-2.0-1.8-0.2 (-0.46, 0.10)
Day 21-2.2-1.9-0.3 (-0.53, 0.01)
Day 28-2.2-2.1-0.1 (-0.37, 0.18)
Day 35-2.1-2.0-0.1 (-0.39, 0.20)
Day 42-2.1-2.10.0 (-0.27, 0.34)
Study 2Time PointDifluprednate Ophthalmic EmulsionN = 50Prednisolone AcetateN = 40Difference(95% CI)
Baseline2.42.40.0 (-0.21, 0.29)
Day 3-0.9-0.9-0.0 (-0.34, 0.25)
Day 7-1.7-1.6-0.1 (-0.35, 0.21)
Day 14-1.9-1.8-0.1 (-0.34, 0.20)
Day 21-2.0-2.00.0 (-0.25, 0.28)
Day 28-2.0-2.00.0 (-0.21, 0.26)
Day 35-2.1-2.0-0.1 (-0.32, 0.16)
Day 42-2.0-1.9-0.1 (-0.36, 0.24)
"],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility Difluprednate was not genotoxic in vitro in the Ames test, and in cultured mammalian cells CHL/IU (a fibroblastic cell line derived from the lungs of newborn female Chinese hamsters). An in vivo micronucleus test of difluprednate in mice was also negative. Treatment of male and female rats with subcutaneous difluprednate up to 10 mcg/kg/day prior to and during mating did not impair fertility in either gender. Long term studies have not been conducted to evaluate the carcinogenic potential of difluprednate. 13.2 Animal Toxicology and/or Pharmacology In multiple studies performed in rodents and non-rodents, subchronic and chronic toxicity tests of difluprednate showed systemic effects such as suppression of body weight gain; a decrease in lymphocyte count; atrophy of the lymphatic glands and adrenal gland; and for local effects, thinning of the skin; all of which were due to the pharmacologic action of the molecule and are well known glucocorticosteroid effects. Most, if not all of these effects were reversible after drug withdrawal. The NOEL for the subchronic and chronic toxicity tests were consistent between species and ranged from 1-1.25 mcg/kg/day."],"spl_unclassified_section":["17 PATIENT COUNSELING INFORMATION 17.1 Risk of Contamination This product is sterile when packaged. Advise patients not to allow the dropper tip to touch any surface, as this may contaminate the emulsion. Use of the same bottle for both eyes is not recommended with topical eye drops that are used in association with surgery. 17.2 Risk of Secondary Infection If pain develops, or if redness, itching, or inflammation becomes aggravated, advise patients to consult a physician. 17.3 Contact Lens Wear Difluprednate ophthalmic emulsion should not be instilled while wearing contact lenses. Advise patients to remove contact lenses prior to instillation of difluprednate ophthalmic emulsion. The preservative in difluprednate ophthalmic emulsion may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of difluprednate ophthalmic emulsion. Manufactured by: Caplin Steriles Limited, Gummidipoondi – 601 201, India. Code:TN/Drugs/TN00003457 Distributed by: Leading Pharma, LLC Fairfield, NJ 07004, USA. Revised: 12/2024 22201168"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION For the treatment of inflammation and pain associated with ocular surgery instill one drop into the conjunctival sac of the affected eye 4 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period, followed by 2 times daily for a week and then a taper based on the response. (2.1) For the treatment of 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. (2.2) 2.1 Ocular Surgery Instill one drop into the conjunctival sac of the affected eye 4 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period, followed by 2 times daily for a week and then a taper based on the response. 2.2 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.","2.1 Ocular Surgery Instill one drop into the conjunctival sac of the affected eye 4 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period, followed by 2 times daily for a week and then a taper based on the response.","2.2 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."],"spl_product_data_elements":["DIFLUPREDNATE DIFLUPREDNATE SODIUM ACETATE EDETATE DISODIUM WATER POLYSORBATE 80 SODIUM HYDROXIDE GLYCERIN CASTOR OIL BORIC ACID SORBIC ACID DIFLUPREDNATE DIFLUPREDNATE"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS Difluprednate ophthalmic emulsion contains 0.05% difluprednate as a sterile preserved emulsion for topical ophthalmic administration. Difluprednate ophthalmic emulsion contains 0.05% difluprednate, as a sterile preserved ophthalmic emulsion for topical ophthalmic use only. (3)"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C. Difluprednate has been shown to be embryotoxic (decrease in embryonic body weight and a delay in embryonic ossification) and teratogenic (cleft palate and skeletal anomalies) when administered subcutaneously to rabbits during organogenesis at a dose of 1-10 mcg/kg/day. The no-observed-effect-level (NOEL) for these effects was 1 mcg/kg/day, and 10 mcg/kg/day was considered to be a teratogenic dose that was concurrently found in the toxic dose range for fetuses and pregnant females. Treatment of rats with 10 mcg/kg/day subcutaneously during organogenesis did not result in any reproductive toxicity, nor was it maternally toxic. At 100 mcg/kg/day after subcutaneous administration in rats, there was a decrease in fetal weights and delay in ossification, and effects on weight gain in the pregnant females. It is difficult to extrapolate these doses of difluprednate to maximum daily human doses of difluprednate ophthalmic emulsion, since difluprednate ophthalmic emulsion is administered topically with minimal systemic absorption, and difluprednate blood levels were not measured in the reproductive animal studies. However, since use of difluprednate during human pregnancy has not been evaluated and cannot rule out the possibility of harm, difluprednate ophthalmic emulsion should be used during pregnancy only if the potential benefit justifies the potential risk to the embryo or fetus. 8.3 Nursing Mothers It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when difluprednate ophthalmic emulsion is administered to a nursing woman. 8.4 Pediatric Use Difluprednate ophthalmic emulsion was evaluated in a 3-month multicenter, double-masked trial in 79 pediatric patients (39 difluprednate; 40 prednisolone acetate) 0 to 3 years of age for the treatment of inflammation following cataract surgery. A similar safety profile was observed in pediatric patients comparing difluprednate ophthalmic emulsion to prednisolone acetate ophthalmic suspension, 1%. 8.5 Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients."],"animal_pharmacology_and_or_toxicology":["13.2 Animal Toxicology and/or Pharmacology In multiple studies performed in rodents and non-rodents, subchronic and chronic toxicity tests of difluprednate showed systemic effects such as suppression of body weight gain; a decrease in lymphocyte count; atrophy of the lymphatic glands and adrenal gland; and for local effects, thinning of the skin; all of which were due to the pharmacologic action of the molecule and are well known glucocorticosteroid effects. Most, if not all of these effects were reversible after drug withdrawal. The NOEL for the subchronic and chronic toxicity tests were consistent between species and ranged from 1-1.25 mcg/kg/day."],"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 69315- 329 -05 Difluprednate ophthalmic emulsion 0.05% For eye use only 5 mL Rx only containerlabel cartonlabel"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility Difluprednate was not genotoxic in vitro in the Ames test, and in cultured mammalian cells CHL/IU (a fibroblastic cell line derived from the lungs of newborn female Chinese hamsters). An in vivo micronucleus test of difluprednate in mice was also negative. Treatment of male and female rats with subcutaneous difluprednate up to 10 mcg/kg/day prior to and during mating did not impair fertility in either gender. Long term studies have not been conducted to evaluate the carcinogenic potential of difluprednate."]},"tags":[{"label":"difluprednate","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Glucocorticoid receptor","category":"target"},{"label":"NR3C1","category":"gene"},{"label":"D07AC19","category":"atc"},{"label":"Ophthalmic","category":"route"},{"label":"Emulsion","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Post-Op Ocular Inflammation","category":"indication"},{"label":"Postoperative Ocular Pain","category":"indication"},{"label":"Sandoz","category":"company"},{"label":"Approved 2000s","category":"decade"},{"label":"Glucocorticoids","category":"pharmacology"},{"label":"Hormones","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"INTRAOCULAR PRESSURE INCREASED","source":"FDA FAERS","actionTaken":"528 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"243 reports"},{"date":"","signal":"EYE PAIN","source":"FDA FAERS","actionTaken":"231 reports"},{"date":"","signal":"VISION BLURRED","source":"FDA FAERS","actionTaken":"184 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"170 reports"},{"date":"","signal":"EYE IRRITATION","source":"FDA FAERS","actionTaken":"165 reports"},{"date":"","signal":"CATARACT","source":"FDA FAERS","actionTaken":"157 reports"},{"date":"","signal":"VISUAL IMPAIRMENT","source":"FDA FAERS","actionTaken":"154 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"130 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"122 reports"}],"commonSideEffects":[{"effect":"Blurred vision","drugRate":"5-10%","severity":"common","_validated":true},{"effect":"Eye irritation","drugRate":"5-10%","severity":"common","_validated":true},{"effect":"Eye pain","drugRate":"5-10%","severity":"common","_validated":true},{"effect":"Headache","drugRate":"5-10%","severity":"common","_validated":true},{"effect":"Increased IOP","drugRate":"5-10%","severity":"common","_validated":true},{"effect":"Iritis","drugRate":"5-10%","severity":"common","_validated":true},{"effect":"Limbal and conjunctival hyperemia","drugRate":"5-10%","severity":"common","_validated":true},{"effect":"Punctate keratitis","drugRate":"5-10%","severity":"common","_validated":true},{"effect":"Uveitis","drugRate":"5-10%","severity":"common","_validated":true},{"effect":"Anterior chamber flare","drugRate":"2-5%","severity":"mild","_validated":true},{"effect":"Corneal edema","drugRate":"2-5%","severity":"mild","_validated":true},{"effect":"Dry eye","drugRate":"2-5%","severity":"mild","_validated":true},{"effect":"Iridocyclitis","drugRate":"2-5%","severity":"mild","_validated":true},{"effect":"Photophobia","drugRate":"2-5%","severity":"mild","_validated":true},{"effect":"Reduced visual acuity","drugRate":"2-5%","severity":"mild","_validated":true}],"contraindications":["Bacterial keratitis","Fungal keratitis","Herpes simplex dendritic keratitis","Herpes zoster keratitis","Ocular hypertension","Tuberculosis of eye","Vaccinia keratitis"],"specialPopulations":{"Pregnancy":"Difluprednate has been shown to be embryotoxic and teratogenic when administered subcutaneously to rabbits during organogenesis at dose of to 10 mcg/kg/day. The use of difluprednate during human pregnancy has not been evaluated and cannot rule out the possibility of harm, difluprednate should be used during pregnancy only if the potential benefit justifies the potential risk to the embryo or fetus.","Geriatric use":"No overall differences in safety or effectiveness have been observed between elderly and younger patients.","Paediatric use":"Safety and effectiveness in pediatric patients has not been established."}},"trials":[],"aliases":[],"company":"Novartis","patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$17.1498/ML","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$6,174","description":"DIFLUPREDNATE 0.05% EYE DROP","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=DIFLUPREDNATE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:10:47.762980+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:10:54.386034+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T01:10:46.395168+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DIFLUPREDNATE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:10:55.225752+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:10:45.176083+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:10:45.176128+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T01:10:56.757645+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL4303220/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:10:55.703138+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA219441","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:10:45.176138+00:00"}},"allNames":"durezol","offLabel":[],"synonyms":["difluprednate","durezol"],"timeline":[{"date":"2008-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from ALCON PHARMS LTD to Sandoz"},{"date":"2008-06-23","type":"positive","source":"DrugCentral","milestone":"FDA approval (Alcon Pharms Ltd)"},{"date":"2021-08-09","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 1 manufacturer approved"}],"aiSummary":"Durezol (difluprednate) is a small molecule glucocorticoid receptor agonist developed by Alcon Pharmaceuticals Ltd and currently owned by Sandoz. It was FDA-approved in 2008 for the treatment of post-operative ocular inflammation and postoperative ocular pain. Durezol is now off-patent with multiple generic manufacturers available. As a glucocorticoid, it works by mimicking the effects of cortisol in the body to reduce inflammation. Its commercial status and pharmacokinetic properties are not well-documented.","approvals":[{"date":"2008-06-23","orphan":false,"company":"ALCON PHARMS LTD","regulator":"FDA"}],"brandName":"Durezol","ecosystem":[{"indication":"Post-Op Ocular Inflammation","otherDrugs":[{"name":"benzalkonium","slug":"benzalkonium","company":""},{"name":"bromfenac","slug":"bromfenac","company":"Bausch And Lomb Inc"},{"name":"cortisone acetate","slug":"cortisone-acetate","company":""},{"name":"dexamethasone","slug":"dexamethasone","company":""}],"globalPrevalence":null},{"indication":"Postoperative Ocular Pain","otherDrugs":[{"name":"bromfenac","slug":"bromfenac","company":"Bausch And Lomb Inc"},{"name":"diclofenac","slug":"diclofenac","company":""},{"name":"ketorolac","slug":"ketorolac","company":""},{"name":"nepafenac","slug":"nepafenac","company":"Alcon Pharms Ltd"}],"globalPrevalence":null}],"mechanism":{"target":"Glucocorticoid receptor","novelty":"Follow-on","targets":[{"gene":"NR3C1","source":"DrugCentral","target":"Glucocorticoid receptor","protein":"Glucocorticoid receptor"}],"modality":"Small Molecule","drugClass":"difluprednate","explanation":"Corticosteroids inhibit the inflammatory response to 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 inammation such as prostaglandins and leukotreines by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.Difluprednate is structurally similar to other corticosteroids.","oneSentence":"Durezol works by binding to glucocorticoid receptors in the body, mimicking the effects of cortisol to reduce inflammation.","technicalDetail":"Difluprednate acts as a potent glucocorticoid receptor agonist, exerting its anti-inflammatory effects by inhibiting the transcription of pro-inflammatory genes and promoting the expression of anti-inflammatory genes.","_target_confidence":0.5},"commercial":{"launchDate":"2008","_launchSource":"DrugCentral (FDA 2008-06-23, ALCON PHARMS LTD)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/3142","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=DIFLUPREDNATE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DIFLUPREDNATE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T10:36:25.636129","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:11:00.826157+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"betamethasone","drugSlug":"betamethasone","fdaApproval":"1961-04-17","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"desoximetasone","drugSlug":"desoximetasone","fdaApproval":"1977-02-28","patentExpiry":"Sep 1, 2028","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"fluocinolone acetonide","drugSlug":"fluocinolone-acetonide","fdaApproval":"1963-02-15","patentExpiry":"Nov 7, 2028","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"fludroxycortide","drugSlug":"fludroxycortide","fdaApproval":"1963-03-19","relationship":"same-class"},{"drugName":"fluocinonide","drugSlug":"fluocinonide","fdaApproval":"1971-06-30","genericCount":23,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"budesonide","drugSlug":"budesonide","fdaApproval":"1994-02-14","patentExpiry":"Sep 9, 2036","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"diflorasone diacetate","drugSlug":"diflorasone-diacetate","fdaApproval":"1977-09-14","genericCount":6,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"amcinonide","drugSlug":"amcinonide","fdaApproval":"1979-10-18","genericCount":4,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"mometasone furoate","drugSlug":"mometasone-furoate","fdaApproval":"1987-04-30","patentExpiry":"Oct 3, 2031","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"beclometasone dipropionate","drugSlug":"beclometasone-dipropionate","fdaApproval":"1976-05-12","relationship":"same-class"},{"drugName":"hydrocortisone aceponate","drugSlug":"hydrocortisone-aceponate","fdaApproval":"","relationship":"same-class"},{"drugName":"fluticasone furoate","drugSlug":"fluticasone-furoate","fdaApproval":"2007-04-27","patentExpiry":"Oct 15, 2028","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"fluticasone propionate","drugSlug":"fluticasone-propionate","fdaApproval":"1990-12-14","patentExpiry":"Sep 26, 2039","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"prednicarbate","drugSlug":"prednicarbate","fdaApproval":"1991-09-23","genericCount":1,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"ulobetasol propionate","drugSlug":"ulobetasol-propionate","fdaApproval":"1990-12-17","relationship":"same-class"}],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"genericName":"difluprednate","indications":{"approved":[{"name":"Post-Op Ocular Inflammation","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"No specific eligibility criteria mentioned"},{"name":"Postoperative Ocular Pain","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"No specific eligibility criteria mentioned"}],"offLabel":[{"name":"Allergic conjunctivitis","source":"DrugCentral","drugName":"DIFLUPREDNATE","evidenceCount":0,"evidenceLevel":"emerging"},{"name":"Cyclitis","source":"DrugCentral","drugName":"DIFLUPREDNATE","evidenceCount":0,"evidenceLevel":"emerging"},{"name":"Iridocyclitis","source":"DrugCentral","drugName":"DIFLUPREDNATE","evidenceCount":0,"evidenceLevel":"emerging"},{"name":"Iritis","source":"DrugCentral","drugName":"DIFLUPREDNATE","evidenceCount":0,"evidenceLevel":"emerging"},{"name":"Uveitis","source":"DrugCentral","drugName":"DIFLUPREDNATE","evidenceCount":52,"evidenceLevel":"strong"}],"pipeline":[]},"currentOwner":"Sandoz","drugCategory":"mature","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"betamethasone","brandName":"betamethasone","genericName":"betamethasone","approvalYear":"1961","relationship":"same-class"},{"drugId":"desoximetasone","brandName":"desoximetasone","genericName":"desoximetasone","approvalYear":"1977","relationship":"same-class"},{"drugId":"fluocinolone-acetonide","brandName":"fluocinolone acetonide","genericName":"fluocinolone acetonide","approvalYear":"1963","relationship":"same-class"},{"drugId":"fludroxycortide","brandName":"fludroxycortide","genericName":"fludroxycortide","approvalYear":"1963","relationship":"same-class"},{"drugId":"fluocinonide","brandName":"fluocinonide","genericName":"fluocinonide","approvalYear":"1971","relationship":"same-class"},{"drugId":"budesonide","brandName":"budesonide","genericName":"budesonide","approvalYear":"1994","relationship":"same-class"},{"drugId":"diflorasone-diacetate","brandName":"diflorasone diacetate","genericName":"diflorasone 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Age-related Macular Degeneration","status":"RECRUITING","sponsor":"Kriya Therapeutics, Inc.","startDate":"2025-05-28","conditions":["Geographic Atrophy Secondary to Age-related Macular Degeneration"],"enrollment":62,"completionDate":"2027-12-15"},{"nctId":"NCT04097730","phase":"PHASE3","title":"Steroids and Cross-linking for Ulcer Treatment","status":"COMPLETED","sponsor":"Thomas M. 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