You are using an outdated browser. Please upgrade your browser to improve your experience and security.

Skip to content
Loading...

FLAREX® SUPPRESSES OCULAR SURFACE INFLAMMATION1

FLAREX was superior vs FML,* P=0.031,a

  • In the FDA pivotal trial, FLAREX demonstrated a statistically significant improvement in speed to resolution of signs and symptoms vs FML, P=0.051

Clinical efficacy of FLAREX vs FML1

68% of ocular surface inflammation was resolved with FLAREX vs 43% with FML within 13 days1

FLAREX offers the efficacy of Pred Forte* for ocular surface inflammation1

In the FDA pivotal trial evaluating patients with ocular surface inflammation,a there was no significant difference in clinical efficacy with FLAREX vs Pred Forte, P=0.49.1

  • No statistically significant difference in speed to resolution of signs and symptoms was observed between FLAREX and Pred Forte, P=0.411

Clinical efficacy of FLAREX vs Pred Forte1

97% of ocular surface inflammation was resolved or improved with FLAREX vs 89% with Pred Forte1

The power of Pred Forte with the safety of FML1-3

FLAREX vs FMLa

  • In a clinical trial, there were no adverse reactions reported in the fluorometholone acetate (FLAREX) and fluorometholone alcohol (FML) treatment groups1

FLAREX vs Pred Fortea

  • In a clinical trial, there were no adverse reactions reported in the fluorometholone acetate (FLAREX) and prednisolone acetate (Pred Forte) treatment groups1

No patients experienced worsening of signs and symptoms in any treatment group1

aSTUDY DESIGN: The efficacy and safety of FLAREX were evaluated in two identical, randomized, double-blind clinical trials. In one trial of 78 patients with ocular surface inflammation (eg, conjunctivitis, episcleritis, scleritis) in one or both eyes, patients administered either FLAREX (n=41) or fluorometholone alcohol (n=37) every 2 hours for the first 2 days and then every 4 hours thereafter, with signs and symptoms of inflammation assessed at Days 1, 3, 8, and 13. In a separate but identical trial in 82 patients with ocular surface inflammation, patients administered either FLAREX (n=37) or prednisolone acetate 1.0% (n=45). At each visit, investigators determined if signs and symptoms in the involved eye were resolved, improved, unchanged, or worsened. If a patient was rated as signs and symptoms resolved before the end of the study, steroid drops were discontinued and the patient was considered to have completed the trial.1

INDICATIONS AND USAGE

FLAREX® (fluorometholone acetate ophthalmic suspension) is indicated for use in the treatment of steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Contraindicated in acute superficial herpes simplex keratitis, vaccinia, varicella, and most other viral diseases of the cornea and conjunctiva; mycobacterial infection of the eye; fungal diseases; acute purulent untreated infections, which like other diseases caused by microorganisms, may be masked or enhanced by the presence of the steroid; and in those persons who have known hypersensitivity to any component of this preparation.

WARNINGS AND PRECAUTIONS

Topical Ophthalmic Use Only: Not for injection.

Intraocular Pressure Increase: Prolonged use may result in glaucoma, damage to the optic nerve, and defects in visual acuity and visual field. It is advisable that the intraocular pressure be checked frequently.

Cataracts: Use of corticosteroids may result in cataract formation.

Delayed Healing: Topical ophthalmic corticosteroids may slow corneal wound healing. In those diseases causing thinning of the cornea or sclera, perforation has been known to occur with chronic use of topical steroids.

Viral Infections: Use in the treatment of herpes simplex infection requires great caution.

Bacterial Infections: Use of corticosteroids may suppress the host response and thus aid in the establishment of secondary ocular infections. Acute purulent infections of the eye may be masked or exacerbated by the presence of steroid medication.

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.

Contamination: Do not touch dropper tip to any surface as this may contaminate the suspension.

Contact Lens Wear: Contact lenses should be removed during instillation of FLAREX but may be reinserted after 15 minutes.

Temporarily Blurred Vision: Vision may be temporarily blurred following dosing with FLAREX. Care should be exercised in operating machinery or driving a motor vehicle.

ADVERSE REACTIONS

Glaucoma with optic nerve damage, visual acuity and field defects, cataract formation, secondary ocular infection following suppression of host response, and perforation of the globe may occur.

Postmarketing Experience: The following reaction has been identified during postmarketing use of FLAREX in clinical practice. Because reactions are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reaction, which has been chosen for inclusion due to either its seriousness, frequency of reporting, possible causal connection to FLAREX, or a combination of these factors, includes dysgeusia.

Please see the Full Prescribing Information.

References: 1. Leibowitz HM, Hyndiuk RA, Lindsey C, et al. Fluorometholone acetate: clinical evaluation in the treatment of external ocular inflammation. Ann Ophthalmol. 1984;16(12):1110-1115. 2. Sendrowski DP, Jaanus SD, Semes LP, et al. Anti-inflammatory drugs. In: Bartlett JD, Jaanus SD, eds. Clinical Ocular Pharmacology. 5th ed. St Louis, MO: Butterworth-Heinemann; 2008:221-244. 3. Shah P, Westwell AD. The role of fluorine in medicinal chemistry. J Enzyme Inhib Med Chem. 2007;22(5):527-540.

+

INDICATIONS AND USAGE

FLAREX® (fluorometholone acetate ophthalmic suspension) is indicated for use in the treatment of steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Contraindicated in acute superficial herpes simplex keratitis, vaccinia, varicella, and most other viral diseases of the cornea and conjunctiva; mycobacterial infection of the eye; fungal diseases; acute purulent untreated infections, which like other diseases caused by microorganisms, may be masked or enhanced by the presence of the steroid; and in those persons who have known hypersensitivity to any component of this preparation.

WARNINGS AND PRECAUTIONS

Topical Ophthalmic Use Only: Not for injection.

Intraocular Pressure Increase: Prolonged use may result in glaucoma, damage to the optic nerve, and defects in visual acuity and visual field. It is advisable that the intraocular pressure be checked frequently.

Cataracts: Use of corticosteroids may result in cataract formation.

Delayed Healing: Topical ophthalmic corticosteroids may slow corneal wound healing. In those diseases causing thinning of the cornea or sclera, perforation has been known to occur with chronic use of topical steroids.

Viral Infections: Use in the treatment of herpes simplex infection requires great caution.

Bacterial Infections: Use of corticosteroids may suppress the host response and thus aid in the establishment of secondary ocular infections. Acute purulent infections of the eye may be masked or exacerbated by the presence of steroid medication.

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.

Contamination: Do not touch dropper tip to any surface as this may contaminate the suspension.

Contact Lens Wear: Contact lenses should be removed during instillation of FLAREX but may be reinserted after 15 minutes.

Temporarily Blurred Vision: Vision may be temporarily blurred following dosing with FLAREX. Care should be exercised in operating machinery or driving a motor vehicle.

ADVERSE REACTIONS

Glaucoma with optic nerve damage, visual acuity and field defects, cataract formation, secondary ocular infection following suppression of host response, and perforation of the globe may occur.

Postmarketing Experience: The following reaction has been identified during postmarketing use of FLAREX in clinical practice. Because reactions are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reaction, which has been chosen for inclusion due to either its seriousness, frequency of reporting, possible causal connection to FLAREX, or a combination of these factors, includes dysgeusia.

Please see the Full Prescribing Information.