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`... Rx Pharmaceuticals (http://www.bausch.com/ecp/Our-Products/Rx-Pharmaceuticals) Rx
`Pharmaceuticals (http://www.bausch.com/ecp/Our-Products/Rx-Pharmaceuticals/Rx-Pharmaceuticals) Alrex (Loteprednol
`Etabonate Ophthalmic Suspension 0.2%) (Http://Www.bausch.com/Ecp/Our-Products/Rx-Pharmaceuticals/Rx-
`Pharmaceuticals/Alrex-Loteprednol-Etabonate-Ophthalmic-Suspension-02)
`
`Alrex (loteprednol etabonate ophthalmic suspension) 0.2%
`
`Alrex ophthalmic suspension (loteprednol etabonate ophthalmic suspension) 0.2%
`is indicated for temporary relief of the signs and symptoms of seasonal allergic
`conjunctivitis.
`1
`
`Alrex contains a C-20 ester corticosteroid that covers many inflammatory mediators
`of the ocular allergic cascade.* Common signs and symptoms that are associated
`with inflamed seasonal allergic conjunctivitis include: itching, tearing, burning,
`redness, foreign-body sensation, and discomfort.
`2
`*There is no generally accepted explanation for the mechanism of action of ocular
`corticosteroids.
`
`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.
`Click here (/Portals/77/-/m/BL/United States/Files/Package Inserts/Pharma/alrex-package-insert.pdf?ver=2017-06-16-
`091104-867) for full Prescribing Information for Alrex.
`
`1. Alrex [package insert]. Tampa, FL: Bausch & Lomb Incorporated; 2013.
`2. Pavesio CE, Decory HH. Treatment of ocular inflammatory conditions with loteprednol etabonate. Br J Ophthalmol.
`2008;92(4):455-459.
`
`ALX.0037.USA.17
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`http://www.bausch.com/ecp/our-products/rx-pharmaceuticals/rx-pharmaceuticals/alrex-loteprednol-etabonate-ophthalmic-suspension-02
`
`MYLAN - EXHIBIT 1089
`Mylan Pharmaceuticals Inc. et al. v. Allergan, Inc.
`IPR2016-01127, -01128, -01129, -01130, -01131, & -01132
`
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