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TREAT OCULAR INFLAMMATION AND INFECTION, AND…

Choose TOBRADEX® ST, formulated with XanGen™, to treat ocular inflammation with risk of bacterial infection

Blepharitis, conjunctivitis, and contact lens acute red eye (CLARE) are some of the most commonly seen inflammatory ocular conditions1-3

Common presentations include:

Lid Margin Disease

Blepharitis/MGD1

  • Ocular surface inflammation
  • Keratitis
  • Scaling, crusting, erythema of the eyelid margin
  • Bacterial overgrowth on lashes (collarettes) and/or meibomian glands

Conjunctivitis

Bacterial and nonspecific2,4

  • Purulent discharge
  • Ocular discomfort and foreign body sensation
  • Tearing
  • Lid crusting

Contact Lens Acute Red Eye (CLARE)3

  • Unilateral eye pain
  • Photophobia
  • Epiphora
  • Conjunctival redness and swelling

Deliver the advantages of TOBRADEX® ST with XanGen™, an innovative suspension technology

Increased viscosity improves ocular bioavailability of drug5

The addition of xanthan gum in TOBRADEX ST5,6:

Elevates the classic combination of tobramycin and dexamethasone

Creates a unique interaction with tears that increases the viscosity of each drop

Provides longer retention on the eye and increased ocular availability of drug

10 minutes after instillation, the tobramycin concentration in tears was 8.3 times higher with TOBRADEX ST vs TobraDex® when compared in a preclinical study5,a

Consistent delivery with minimal settling 24 hours after mixing5,b

Percentage of dexamethasone per label in each drop expressed from the bottle after 24 hours5

Higher percentage of dexamethasone in each drop of TOBRADEX ST compared to TobraDex.

Percentage of dexamethasone that remained suspended after 24 hours5

Higher percentage of dexamethasone suspended with TOBRADEX ST compared to TobraDex after 24 hours.
Based on the results of a preclinical study that examined the concentration of tobramycin in rabbit tears following exposure to TOBRADEX ST and TobraDex.5
Based on the results of a preclinical study that examined the suspension-settling characteristics of TOBRADEX ST compared to TobraDex.5

There is no therapeutic equivalent of TOBRADEX ST7

Preclinical Data

Increase bactericidal activity with TOBRADEX® ST

TOBRADEX ST exhibited greater and more rapid bactericidal activity than TobraDex® against tobramycin- and methicillin-resistant strains5

Based on the results of a preclinical study that examined the effectiveness in killing S aureus and S pneumoniae isolates using tobramycin concentrations measured 10 minutes following exposure to TOBRADEX ST or TobraDex in rabbit models5

>99.9%

TOBRADEX ST killed >99.9% of S aureus compared to 0% by TobraDex

More bacteria were killed with TOBRADEX ST compared to TobraDex.
5 min

TOBRADEX ST killed >99.9% of S pneumoniae within 5 min compared to 120 min for TobraDex

More bacteria were killed at a greater rate with TOBRADEX ST compared to TobraDex.

Clinical Data

Half the dexamethasone, similar ocular tissue exposure5

33.7
ng/mL

TOBRADEX® ST

vs

30.9
ng/mL

TobraDex®

In a pharmacokinetic study, the concentration of dexamethasone in the aqueous humor 2 hours after instillation was 33.7±22.8 ng/mL for patients receiving TOBRADEX ST and 30.9±16.7 ng/mL for patients receiving TobraDex.a

Provide patients rapid relief with TOBRADEX ST8

After 1 week of TOBRADEX ST dosing, patients had significant reduction in symptoms8,b

TOBRADEX ST provides relief from symptoms associated with blepharitis/blepharoconjunctivitis.

Global symptom score was determined from the following symptoms, often associated with blepharitis/blepharoconjunctivitis8

  • Lid margin redness
  • Ocular discharge
  • Bulbar conjunctival redness
  • Palpebral conjunctival redness
  • Lid swelling
  • Itchy eyelids
  • Gritty eyes

No IOP spikes were reported during the first week of treatment. At the 2-week visit, 3 of 61 patients treated with TOBRADEX ST (4.9%) had an increase in IOP with only 1 patient having an increase of >10 mmHg8

Multicenter, double-blind, parallel-group, single-dose study of 987 patients receiving a single dose of TOBRADEX ST or TobraDex ophthalmic suspension.5
Randomized, multicenter, investigator-masked, active-controlled, parallel-group trial conducted in adult patients who had moderate to severe blepharitis/blepharoconjunctivitis.8

The ST makes a difference. Prescribe TOBRADEX ST.

Deliver the difference of TOBRADEX® ST

Dosing and administration6

  • One drop of TOBRADEX ST should be administered to the affected eye every 4 to 6 hours
    • During the initial 24 to 48 hours, dosage may be increased to one drop every 2 hours
  • Frequency should be decreased gradually as clinical signs improve
  • Therapy should not be discontinued prematurely
Prescribe 1 drop of TOBRADEX ST every 4 to 6 hours.

Eyevance® is committed to helping all patients have affordable access to TOBRADEX® ST

With our copay savings program, eligible patientsa could pay as little as $45

Savings >

aEligible patients include those whose prescriptions are covered by commercial insurance and patients whose TOBRADEX ST prescriptions are not covered by either commercial or government insurance. See full terms and conditions at myeyesavings.com for commercial, Medicare Part D, cash pay, and government insurance patients.

Indication and Usage

For steroid responsive inflammatory ocular conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe and chronic anterior uveitis, corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies for which a corticosteroid is indicated and where the risk of superficial bacterial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

Important Safety Information

CONTRAINDICATIONS:

Most viral disease 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 disease of ocular structures. Hypersensitivity to any components of the medication.

WARNINGS & PRECAUTIONS:

  • IOP increase — Prolonged use may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. IOP should be monitored.
  • Aminoglycoside sensitivity — Sensitivity to topically applied aminoglycosides may occur.
  • Cataracts — Posterior subcapsular cataract formation may occur.
  • Delayed healing — May delay healing and increase the incidence of bleb formation. Perforations of the cornea or sclera have occurred. Slit lamp biomicroscopy, and fluorescein staining should be conducted.
  • Bacterial infections — May suppress host response and increase secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.
  • Viral infections — Use with history of herpes simplex requires great caution. The course and severity of many viral infections of the eye (including herpes simplex) may be exacerbated.
  • Fungal infections — Fungal infections of the cornea may occur and should be considered in any persistent corneal ulceration.
  • Use with systemic aminoglycosides — Total serum concentration of tobramycin should be monitored.

ADVERSE REACTIONS:

The most frequent adverse reactions (<4%) to topical ocular tobramycin are hypersensitivity and localized ocular toxicity, including eye pain, eyelid pruritus, eyelid edema, and conjunctival hyperemia.

The reactions due to the steroid component are increased intraocular pressure with possible development of glaucoma, and infrequent optic nerve disorder; subcapsular cataract; and impaired healing.

The development of secondary infection has occurred. Fungal infections of the cornea may occur. Secondary bacterial ocular infection following suppression of host responses also occurs.

Non-ocular adverse events (0.5% to 1%) included headache and increased blood pressure.

Please see the Full Prescribing Information.

IOP=intraocular pressure; MGD=meibomian gland dysfunction.

References: 1. Amescua G, Akpek EK, Farid M, et al. Blepharitis Preferred Practice Pattern®. Ophthalmology. 2019;126(1):P56-P93. 2. Tey A. Types, presentations and management of conjunctivitis. Prescriber. May 2009:26-38. 3. Sicks LA. Bringing clarity to CLARE: understanding and knowing how to treat this common contact lens complication can benefit both your patients and your practice. Rev Cornea Contact Lens. 2015:1-5. https://www.reviewofcontactlenses.com/article/bringing-clarity-to-clare. Accessed December 9, 2019. 4. American Optometric Association Consensus Panel on Care of the Patient With Conjunctivitis. Optometric Clinical Practice Guideline: Care of the Patient With Conjunctivitis. 2nd ed. St. Louis, MO: American Optometric Association; 2002. 5. Scoper SV, Kabat AG, Owen GR, et al. Ocular distribution, bactericidal activity and settling characteristics of TobraDex® ST ophthalmic suspension compared with TobraDex® ophthalmic suspension. Adv Ther. 2008;25(2):77-88. 6. TOBRADEX® ST Suspension [package insert]. Fort Worth, TX: Eyevance Pharmaceuticals LLC; 2011. 7. US Department of Health and Human Services, Food and Drug Administration. Approved drug products with therapeutic equivalence evaluations. (Orange Book). 38th ed. Washington, DC: US Department of Health and Human Services, Food and Drug Administration; 2018. 8. Torkildsen GL, Cockrum P, Meier E, et al. Evaluation of clinical efficacy and safety of tobramycin/dexamethasone ophthalmic suspension 0.3%/0.05% compared to azithromycin ophthalmic solution 1% in the treatment of moderate to severe acute blepharitis/blepharoconjunctivitis. Curr Med Res Opin. 2011;27(1):171-178.

Indication and Usage

For steroid responsive inflammatory ocular conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe and chronic anterior uveitis, corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies for which a corticosteroid is indicated and where the risk of superficial bacterial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

Important Safety Information

CONTRAINDICATIONS:

Most viral disease 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 disease of ocular structures. Hypersensitivity to any components of the medication.

WARNINGS & PRECAUTIONS:

  • IOP increase — Prolonged use may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. IOP should be monitored.
  • Aminoglycoside sensitivity — Sensitivity to topically applied aminoglycosides may occur.
  • Cataracts — Posterior subcapsular cataract formation may occur.
  • Delayed healing — May delay healing and increase the incidence of bleb formation. Perforations of the cornea or sclera have occurred. Slit lamp biomicroscopy, and fluorescein staining should be conducted.
  • Bacterial infections — May suppress host response and increase secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.
  • Viral infections — Use with history of herpes simplex requires great caution. The course and severity of many viral infections of the eye (including herpes simplex) may be exacerbated.
  • Fungal infections — Fungal infections of the cornea may occur and should be considered in any persistent corneal ulceration.
  • Use with systemic aminoglycosides — Total serum concentration of tobramycin should be monitored.

ADVERSE REACTIONS:

The most frequent adverse reactions (<4%) to topical ocular tobramycin are hypersensitivity and localized ocular toxicity, including eye pain, eyelid pruritus, eyelid edema, and conjunctival hyperemia.

The reactions due to the steroid component are increased intraocular pressure with possible development of glaucoma, and infrequent optic nerve disorder; subcapsular cataract; and impaired healing.

The development of secondary infection has occurred. Fungal infections of the cornea may occur. Secondary bacterial ocular infection following suppression of host responses also occurs.

Non-ocular adverse events (0.5% to 1%) included headache and increased blood pressure.

Please see the Full Prescribing Information.