Difluprednate

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.

• 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.

• 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.contraindicated

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.

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).

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.

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.

Metabolism

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.

• Jun 23, 2008NDANDA022212Sandoz
• Aug 9, 2021ANDAANDA211776Cipla
• Nov 17, 2021ANDAANDA211526Amneal
• Nov 16, 2022ANDAANDA214894Dr Reddys
• Dec 13, 2024ANDAANDA219441Caplin
• Feb 11, 2025ANDAANDA218191Upsher Smith Labs
• Mar 20, 2025ANDAANDA212566Mylan Labs Ltd
• Jan 26, 2026ANDAANDA213774Alembic

1. 1Intraocular Pressure Increased52814%
2. 2Drug Ineffective2446.5%
3. 3Eye Pain2316.1%
4. 4Vision Blurred1864.9%
5. 5Off Label Use1714.5%
6. 6Eye Irritation1674.4%
7. 7Cataract1584.2%
8. 8Visual Impairment1544.1%
9. 9Fatigue1303.5%
10. 10Headache1223.2%
11. 11Therapy Partial Responder1052.8%
12. 12Uveitis972.6%
13. 13Diarrhoea962.5%
14. 14Eye Inflammation942.5%
15. 15Chronic Kidney Disease872.3%

The 10 most recently updated of 25 ClinicalTrials.gov registrations naming Difluprednate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Evaluate KRIYA-825 (VV-14295) in Adults With Geographic Atrophy Secondary to Age-related Macular Degeneration
  Recruiting · Phase 1 · Phase 2 · Interventional · 62 enrolled · Kriya Therapeutics, Inc.
  NCT06765980updated 2026-04-30
• Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II
  Active not recruiting · Phase 3 · Interventional · 60 enrolled · University of California, San Francisco
  NCT06271772updated 2025-12-18
• Steroids and Cross-linking for Ulcer Treatment
  Completed · Phase 3 · Interventional · 280 enrolled · Thomas M. Lietman
  NCT04097730updated 2025-02-03
• Difluprednate vs. a Prednisolone Acetate - Phenylephrine on Post-operative Inflammation Following Cataract Surgery.
  Completed · Phase 4 · Interventional · 255 enrolled · Laboratorios Poen
  NCT04631315updated 2023-05-12
• A Study of the Effect of Different Doses of Difluprednate Eye Drops on the Intraocular Pressure After Phacoemulsification
  Unknown · Phase 4 · Interventional · 20 enrolled · Kafrelsheikh University
  NCT05649111updated 2022-12-13
• Clinical Investigation of the Dextenza 0.4mg Intracanalicular Insert Delivery System Used in Cataract Surgery
  Terminated · Phase 4 · Interventional · 1 enrolled · Cathleen McCabe MD
  NCT04687800updated 2022-11-10
• Topical Corticosteroid Use in Addition to Oral Antivirals for Prevention of Recurrence of Herpes Simplex Virus (HSV) Keratitis
  Withdrawn · Phase 4 · Interventional · 0 enrolled · NYU Langone Health
  NCT03626376updated 2022-01-14
• Macular Edema Nepafenac vs. Difluprednate Uveitis Trial
  Terminated · Phase 4 · Interventional · 9 enrolled · University of California, San Francisco
  NCT01939691updated 2021-01-13
• Clinical Study of the Efficacy of the Ophthalmic Emulsion PRO-145 for Inflammation and Pain After Phacoemulsification
  Completed · Phase 3 · Interventional · 178 enrolled · Laboratorios Sophia S.A de C.V.
  NCT03693989updated 2019-12-02
• Non Neutralizing Antibodies: Prevalence and Characterization
  Withdrawn · Observational · 0 enrolled · University Hospital, Montpellier
  NCT01541527updated 2014-12-31

Frequently asked questions

How does Difluprednate work?

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.

What is Difluprednate used for?

According to FDA labeling, Difluprednate carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Difluprednate?

Difluprednate is classified as Corticosteroids, plain, Corticosteroids, potent (group III).

What are the brand names for Difluprednate?

Difluprednate is marketed under brand names including Durezol.

What are the contraindications for Difluprednate?

Difluprednate labeling lists contraindications including: 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.. Always consult the full prescribing information and a clinician.