ZYLET HAS A LOWER INCIDENCE OF IOP ELEVATION COMPARED TO TOBRADEX1*

In a head-to-head safety study against TobraDex in healthy volunteers, intraocular pressure (IOP) elevation was seen significantly less frequently with ZYLET.1

SUBJECTS IN EACH STUDY GROUP WITH IOP CHANGES ≥10 MM HG OVER BASELINE1†
Graph showing the percentage of subjects with IOP increase greater than or equal to 10 mm Hg over baseline during the testing period: ZYLET resulted in 1.95% vs TOBRADEX with 7.48% of subjects with occurrences of increased IOP Graph showing the percentage of subjects with IOP increase greater than or equal to 10 mm Hg over baseline during the testing period: ZYLET resulted in 1.95% vs TOBRADEX with 7.48% of subjects with occurrences of increased IOP

†Study Design: 306 healthy volunteers received either ZYLET (n=156) or TobraDex (n=150) at 4-hour intervals 4 times a day in both eyes for 28 days in a randomized, double-masked, multicenter, parallel-group trial. Primary endpoint was the occurrence of any IOP increase ≥10 mm Hg over baseline in either eye at any study visit (days 1, 3, 8, 15, 22, and 29).1

*If ZYLET is used for 10 days or longer, IOP should be monitored.2 Please see additional Important Safety Information below.

THE STRUCTURE OF LOTEPREDNOL

ZYLET is an ophthalmic suspension formulated with loteprednol etabonate 0.5% and tobramycin 0.3%. Loteprednol is a C-20 ester corticosteroid, which allows ocular esterases to break down the active corticosteroid into inactive metabolites. This may result in a lower potential for adverse events, such as increased intraocular pressure.2-4

Image showing active (loteprednol etabonate) and inactive (17B-carboxylic acid) metabolites of ZYLETImage showing active (loteprednol etabonate) and inactive (17B-carboxylic acid) metabolites of ZYLET

COMBINED STRENGTH OF A BROAD-SPECTRUM ANTIBIOTIC AND CORTICOSTEROID

ZYLET has proven efficacy comparable to TobraDex for treatment of the signs and symptoms of blepharokeratoconjunctivitis.5

ESTABLISHED EFFICACY IN THE TREATMENT OF BLEPHAROKERATOCONJUNCTIVITIS: ZYLET VS TOBRADEX5‡
Graph showing mean change from baseline in the signs and symptoms composite score over 15 days of treatment with ZYLET vs TOBRADEX for blepharokeratoconjunctivitis Graph showing mean change from baseline in the signs and symptoms composite score over 15 days of treatment with ZYLET vs TOBRADEX for blepharokeratoconjunctivitis

‡For all 3 study visits, the 90% confidence interval for the difference in change from baseline between treatment groups contained 0, indicating no statistically significant difference between treatment groups.

§Range of signs and symptoms composite score: 0-52.

||Day 15 was the primary efficacy endpoint.

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DOSING WITH ZYLET

See the dosing, administration, and handling information for ZYLET.

 
 
Indications and Usage

ZYLET (loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension) is a topical anti‑infective and corticosteroid combination for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, and where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies.

The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

The particular anti-infective drug in this product (tobramycin) is active against the following common bacterial eye pathogens: Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains. Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae, and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.

Important Safety Information
  • ZYLET 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 infections of the eye and fungal diseases of ocular structures.
  • Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, and defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. If this product is used for 10 days or longer, intraocular pressure should be monitored.
  • Use of corticosteroids may result in posterior subcapsular cataract formation.
  • The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification such as a slit lamp biomicroscopy and, where appropriate, fluorescein staining.
  • Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infections. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.
  • Employment of corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and exacerbate the severity of many viral infections of the eye (including herpes simplex).
  • 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.
  • Most common adverse reactions reported in patients were injection and superficial punctate keratitis, increased intraocular pressure, and burning and stinging upon instillation.

Please click here for Prescribing Information about ZYLET.

References: 1. Holland EJ, Bartlett JD, Paterno MR, Usner DW, Comstock TL. Effects of loteprednol/tobramycin versus dexamethasone/tobramycin on intraocular pressure in healthy volunteers. Cornea. 2008;27(1):50-55. 2. ZYLET [package insert]. Tampa, FL: Bausch & Lomb Incorporated; 2016. 3. Novack GD, Howes J, Crockett RS, Sherwood MB. Change in intraocular pressure during long-term use of loteprednol etabonate. J Glaucoma. 1998;7(4):266-269. 4. Bodor N, Buchwald P. Ophthalmic drug design based on the metabolic activity of the eye: soft drugs and chemical delivery systems. The AAPS J. 2005;7(4):E820-E833. 5. White EM, Macy JI, Bateman KM, Comstock TL. Comparison of the safety and efficacy of loteprednol 0.5%/tobramycin 0.3% with dexamethasone 0.1%/tobramycin 0.3% in the treatment of blepharokeratoconjunctivitis. Curr Med Res Opin. 2008;24(1):287-296.

Indications and Usage

ZYLET (loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension) is a topical anti‑infective and corticosteroid combination for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, and where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies.

The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

The particular anti-infective drug in this product (tobramycin) is active against the following common bacterial eye pathogens: Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains. Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae, and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.

Important Safety Information
  • ZYLET 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 infections of the eye and fungal diseases of ocular structures.
  • Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, and defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. If this product is used for 10 days or longer, intraocular pressure should be monitored.
  • Use of corticosteroids may result in posterior subcapsular cataract formation.
  • The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification such as a slit lamp biomicroscopy and, where appropriate, fluorescein staining.
  • Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infections. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.
  • Employment of corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and exacerbate the severity of many viral infections of the eye (including herpes simplex).
  • 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.
  • Most common adverse reactions reported in patients were injection and superficial punctate keratitis, increased intraocular pressure, and burning and stinging upon instillation.

Please click here for Prescribing Information about ZYLET.