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The power of Pred Forte* (prednisolone acetate ophthalmic suspension, USP) 1% with the safety of FML* (fluorometholone ophthalmic suspension, USP) 0.1%¹

*Trademarks referenced herein held by their respective owners.

FLAREX 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.^2-5:

Surgical procedures can induce inflammation, including LASIK, PRK, corneal cross-linking, and other ocular surface surgical procedures^6-8

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

FLAREX is refined for efficacy^10-12

FLAREX is a steroid ester and the only acetate derivative of fluorometholone.^1,3,12

The acetate group improves lipophilicity, allowing greater penetration across the cell membranes of the cornea¹¹

SEE CLINICAL TRIAL DATA

INDICATIONS AND USAGE

FLAREX^® (fluorometholone acetate ophthalmic suspension) 0.1% 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: 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 15 minutes after instillation.

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.

The following rare adverse reactions have been reported: Cushing’s syndrome and adrenal suppression may occur after very frequent use of topical ophthalmic corticosteroids, particularly in very young children.

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. Flarex. Prescribing information. Eyevance Pharmaceuticals LLC; 2022. 3. Charters L. Ocular surface inflammation: vicious cycle of ocular surface disruption. Ophthalmology Times. October 16, 2019. Accessed May 19, 2021. https://www.ophthalmologytimes.com/view/ocular-surface-inflammation-vicious-cycle-ocular-surface-disruption. 4. Perez VL, Stern ME, Pflugfelder SC. Inflammatory basis for dry eye disease flares. Exp Eye Res. 2020;201:108294. 5. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US Department of Health and Human Services, Food and Drug Administration. Accessed April 25, 2021. https://www.accessdata.fda.gov/scripts/cder/ob/search_product.cfm. 6. Solomon R, Donnenfeld ED, Petty HD. The effects of LASIK on the ocular surface. Ocul Surf. 2004;2(1):34-44. 7. Mikalauskiene L, Grzybowski A, Zemaitiene R. Ocular surface changes associated with ophthalmic surgery. J Clin Med. 2021;10(8):1642. 8. Hafezi F, Hillen M, Kollros L, Tan J, Awwad ST. A new postoperative regimen after CXL and PRK using topical NSAID and steroids on the open ocular surface. J Clin Med. 2022;11(14):4109. 9. Craig JP, Nichols KK, Akpek EK, et al. TFOS DEWS II Definition and Classification report. Ocul Surf. 2017;15(3)276-283. 10. 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. 11. Sendrowski DP, Jaanus SD, Semes LP, Stern ME. Anti-inflammatory drugs. In: Bartlett JD, Jaanus SD, eds. Clinical Ocular Pharmacology. 5th ed. St Louis, MO: Butterworth-Heinemann, an imprint of Elsevier Inc; 2008:221-244. 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 Compound Summary for CID 240767, Fluorometholone acetate. Accessed September 10, 2020. https://pubchem.ncbi.nlm.nih.gov/compound/fluorometholone-acetate.