A C-20 Ester Corticosteroid With a Favorable Safety Profile

After exerting its therapeutic effects, ALREX is converted into inactive metabolites, which may result in a lower potential for adverse events, such as increased IOP.¹

Low incidence of elevated IOP in two 6-week clinical trials¹

ALREX showed rates of IOP elevation similar to placebo in patients with SAC.^*†

Only 1 patient taking ALREX experienced a clinically significant increase in IOP (≥10 mm Hg) throughout the 6-week trials (n=133).

IOP, intraocular pressure; SAC, seasonal allergic conjunctivitis.

*Study design: Two 6-week, double-masked, placebo-controlled, multicenter environmental studies conducted during pollen season in which patients (N=268) with moderate to severe signs and symptoms of SAC bilaterally received ALREX (0.2%) or placebo QID for 42 days. Primary efficacy variables were bulbar conjunctival injection (signs) and ocular itching (symptoms) resolution at Day 14. Supportive outcome measures included discomfort, foreign body sensation, burning/stinging, and discharge.^2,3

^†If ALREX is used for more than 10 days, IOP should be monitored.¹

FORMULATED FOR PATIENT COMFORT WITH THE MOISTURIZING INGREDIENTS POVIDONE AND GLYCERIN¹

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SAC, seasonal allergic conjunctivitis.

INDICATION

ALREX^® (loteprednol etabonate ophthalmic suspension) 0.2% is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.

IMPORTANT SAFETY INFORMATION

ALREX is contraindicated in most 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 the ocular structures. ALREX is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
Prolonged use of ALREX is associated with several warnings and precautions, including glaucoma with optic nerve damage, defects in visual acuity, cataract formation, secondary ocular infections, exacerbation or prolongation of viral ocular infections (including herpes simplex), delay in wound healing and increase in bleb formation.
If this product is used for 10 days or longer, intraocular pressure should be monitored. The initial prescription and renewal of the medication order beyond 14 days should be made by a physician only after reexamination of the patient with the aid of magnification. Fungal infections of the cornea may develop with prolonged use of corticosteroids.
Ocular adverse reactions occurring in 5-15% of patients treated with loteprednol etabonate ophthalmic suspension (0.2% - 0.5%) in clinical studies included abnormal vision/blurring, burning on instillation, chemosis, discharge, dry eyes, epiphora, foreign body sensation, itching, injection, and photophobia.

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References: 1. ALREX [package insert]. Tampa, FL: Bausch & Lomb Incorporated; 2019. 2. Shulman DG, Lothringer LL, Rubin JM, et al. A randomized, double-masked, placebo-controlled parallel study of loteprednol etabonate 0.2% in patients with seasonal allergic conjunctivitis. Ophthalmology. 1999;106(2):362-369. 3. Dell SJ, Lowry GM, Northcutt JA, et al. A randomized, double-masked, placebo-controlled parallel study of 0.2% loteprednol etabonate in patients with seasonal allergic conjunctivitis. J Allergy Clin Immunol. 1998:102(2):251-255.