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FLAREX®—effective against inflammation with a broad indication1

FLAREX is the only branded steroid indicated for ocular surface inflammation, providing the opportunity to treat inflammation associated with a wide range of ocular surface conditions1-4:

Additionally, surgical procedures can induce inflammation, including LASIK, PRK, corneal cross-linking, and other ocular surface surgical procedures5-9

LASIK=laser-assisted in situ keratomileusis; PRK=photorefractive keratectomy.

OCULAR SURFACE INFLAMMATION IS A KEY ETIOLOGICAL FACTOR IN DRY EYE DISEASE10

The definition of dry eye disease by Tear Film & Ocular Surface Society Dry Eye Workshop II (TFOS DEWS II*) highlights its complexity and relationship with ocular surface inflammation10:

FLAREX is refined for improved efficacy2,11,12

FLAREX is a steroid ester and the only acetate derivative of fluorometholone.1,3,13

The acetate group improves lipophilicity, allowing greater penetration across the cell membrane2

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. FLAREX [package insert]. Fort Worth, TX: Alcon Laboratories, Inc; 2017. 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. US Department of Health and Human Services, Food and Drug Administration. Approved drug products with therapeutic equivalence evaluations. (Orange Book). 40th ed. Washington, DC: US Department of Health and Human Services, Food and Drug Administration; 2020. 4. Abelson MB, Smith L. A stepwise approach to acute dry eye. Rev Ophthalmol. https://www.reviewofophthalmology.com/article/a-stepwise-approach-to-acute-dry-eye. Accessed September 10, 2020. 5. Murrill CA, Stanfield DL, VanBrocklin MD. Postoperative care of the cataract patient. In: Bartlett JD, Jaanus SD, eds. Clinical Ocular Pharmacology. 5th ed. St Louis, MO: Butterworth-Heinemann; 2008:601-615. 6. Badalà F, Fioretto M, Macrì A. Effect of topical 0.1% indomethacin solution versus 0.1% fluorometholon acetate on ocular surface and pain control following laser subepithelial keratomileusis (LASEK). Cornea. 2004;23(6):550-553. 7. Steinert RF, McColgin AZ, Garg S. Laser in situ keratomileusis (LASIK). American Academy of Ophthalmology. https://www.aao.org/munnerlyn-laser-surgery-center/laser-in-situ-keratomileusis-lasik-3. Accessed September 24, 2020. 8. Ozgurhan EB, Kara N, Bozkurt E, et al. Effect of fluorometholone/tetrahydrozoline fixed combination on conjunctival autograft morphology after primary pterygium excision. Biomed Res Int. 2013;2013:481843. 9. Ibach M. Go thin for the win: a review of endothelial keratoplasty. Rev Optom. https://www.reviewofoptometry.com/article/go-thin-for-the-win-a-review-of-endothelial-keratoplasty. Accessed September 24, 2020. 10. Craig JP, Nichols KK, Akpek EK, et al. TFOS DEWS II Definition and Classification report. Ocul Surf. 2017;15(3):276-283. doi: 10.1016/j.jtos.2017.05.008. 11. 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. 12. Shah P, Westwell AD. The role of fluorine in medicinal chemistry. J Enzyme Inhib Med Chem. 2007;22(5):527-540. 13. National Center for Biotechnology Information, PubChem. Fluorometholone acetate. https://pubchem.ncbi.nlm.nih.gov/compound/fluorometholone-acetate. Accessed September 10, 2020.

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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.