Safety Profile for Ocular Surgery

Safety Profile for Patients Based on Ocular Surgery Clinical Trials

The most common ocular adverse reactions occurring in 5%-15% of subjects in clinical studies with DUREZOL® Emulsion included corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacification, anterior chamber cells, anterior chamber flare, conjunctival edema, and blepharitis.1

Mean Intraocular Pressure (IOP) in Clinical Trials for Patients Undergoing Cataract Surgery2

  • 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 monitored1
  • A clinically significant IOP rise (≥21 mm Hg; ≥10 mm Hg from baseline) was observed in 3 patients (3%) in the DUREZOL® Emulsion group and 2 patients (1%) in the placebo group2
  • One patient in the DUREZOL® Emulsion group and both patients in the placebo group required IOP-lowering medication2

Data from 2 randomized, double-masked, placebo-controlled trials in patients with an anterior chamber cell count ≥11 one day after cataract surgery. Patients self-instilled 1 drop of DUREZOL® (difluprednate ophthalmic emulsion) 0.05% or placebo 4 times daily beginning 1 day after surgery and continuing throughout the first 2 weeks of the postoperative period, followed by 2 times daily for a week and then once daily for 1 week. The complete clearing of cells (a cell count of 0) was assessed, as was the percentage of patients who were pain free. Results are from an intent-to-treat analysis.

EVALUATION OF PAIN

Symptoms of pain and discomfort were collected at each visit and graded 0 to 100 according to a visual analogue scale (VAS) that used a mark on a 100-mm line (with anchor points of 0=absent and 100=maximal pain or discomfort).3,4 

INDICATIONS AND USAGE

DUREZOL® (difluprednate ophthalmic emulsion) 0.05% is a topical corticosteroid that is indicated for:

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

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.
  • 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.

IMPORTANT SAFETY INFORMATION

Contraindications

DUREZOL® 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.

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.
  • Cataracts – Use of corticosteroids may result in posterior subcapsular cataract formation.
  • 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.
  • 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.
  • 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).
  • 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.
  • Contact lens wear – DUREZOL® Emulsion should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of DUREZOL® Emulsion. The preservative in DUREZOL® Emulsion may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of DUREZOL® Emulsion.

Most Common Adverse Reactions

  • In postoperative ocular inflammation and pain studies, ocular adverse reactions occurring in 5‐15% of subjects included corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacification, anterior chamber cells, anterior chamber flare, conjunctival edema, and blepharitis.
  • In the endogenous anterior uveitis studies, the most common adverse reactions 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.

For additional information on DUREZOL® Emulsion, please click here to view full Prescribing Information.

IMPORTANT SAFETY INFORMATION

Contraindications

DUREZOL® 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.

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.
  • Cataracts – Use of corticosteroids may result in posterior subcapsular cataract formation.
  • 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.
  • 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.
  • 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).
  • 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.
  • Contact lens wear – DUREZOL® Emulsion should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of DUREZOL® Emulsion. The preservative in DUREZOL® Emulsion may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of DUREZOL® Emulsion.

Most Common Adverse Reactions

  • In postoperative ocular inflammation and pain studies, ocular adverse reactions occurring in 5‐15% of subjects included corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacification, anterior chamber cells, anterior chamber flare, conjunctival edema, and blepharitis.
  • In the endogenous anterior uveitis studies, the most common adverse reactions 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.

INDICATIONS AND USAGE

DUREZOL® (difluprednate ophthalmic emulsion) 0.05% is a topical corticosteroid that is indicated for:

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

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.
  • 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.

For additional information on DUREZOL® Emulsion, please click here to view full Prescribing Information.

References: 1. Durezol [package insert]. Fort Worth, TX: Alcon Laboratories, Inc; 2017. 2. Korenfeld MS, Silverstein SM, Cooke DL, Vogel R, Crockett RS; Difluprednate Ophthalmic Emulsion 0.05% (Durezol) Study Group. Difluprednate ophthalmic emulsion 0.05% for postoperative inflammation and pain. J Cataract Refract Surg. 2009;35(1):26-34. 3. Data on file. Study ST-601A-002a. Novartis Pharmaceuticals Corp; September 2007. 4. Data on file. Study ST-601A-002b. Novartis Pharmaceuticals Corp; September 2007.