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When Blepharitis/MGD Strikes Stop Flares Fast
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Click to see Why ST MATTERS!

Inflammation must be controlled to improve symptoms and prevent long-term damage.2

Cycle of inflammation and infection in blepharitis/MGD3

Lipid Changes
  • This inflammation affects the ability of the meibomian glands to produce oil and alters the normal lipid composition of the oils3
Break down of oil layer
  • Bacterial release of lipases can break down and interrupt the healthy, smooth oil layer3
Bacterial Overpopulation
  • When there is bacterial overgrowth on your eyelids, there may be unwanted consequences3
Inflammatory Toxins
  • Bacterial release of inflammatory toxins contributes to inflammation3

The American Academy of Ophthalmology recommends combination antibiotic/corticosteroid therapy for patients with blepharitis/MGD who experience acute flare-ups.4

  • MGD=meibomian gland dysfunction.

RAPID RELIEF from Acute Blepharitis/MGD Flares1

After 1 week of TOBRADEX® ST dosing, patients had >50% reduction in symptoms1,a

Global symptom score was determined from the following symptoms often associated with blepharitis/blepharoconjunctivitis1

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No IOP spikes were reported during the first week of treatment.1

  • a Randomized, investigator-masked, active-controlled, parallel-group trial conducted at 7 private practice clinical sites in the United States with 122 adult patients who had moderate to severe blepharitis/blepharoconjunctivitis.1
  • IOP=intraocular pressure.

DELIVER THE ADVANTAGES OF TOBRADEX ST WITH THE STAYING POWER OF XANGEN®5

In a preclinical study, increased viscosity improved ocular retention and bioavailability5,b

Why ST  MATTERS!

The XanGen formulation of TOBRADEX ST creates a unique interaction with tears that increases the viscosity of each drop to provide longer ocular retention on the eye and increased ocular bioavailability of drug without causing visual blurriness5,6,b

  • b Demonstrated in a preclinical study utilizing a rabbit model that closely mimics the human eye.5

TOBRADEX ST suspension benefits vs ointment products7-9

XANGEN SUSPENSION TECHNOLOGY

Particles retain in lower precorneal pocket and improve drug contact time and duration of action relative to drug solution7

OINTMENT

Sticky and inconvenient; may cause irritation and interference with vision8,9

Consistent delivery of dexamethasone with minimal settling5

TOBRADEX ST delivers 12.5x higher tobramycin concentration in ocular tissue compared to TobraDex5

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

  • b Based on the results of a preclinical study that examined the suspension settling characteristics of TOBRADEX ST compared to TobraDex.

TOBRADEX® ST MORE EFFECTIVELY KILLS METHICILLIN-RESISTANT STAPH AUREUS (MRSA) THAN TOBRADEX* (>99.9% KILL RATE VS 0%)5

In a preclinical study, TOBRADEX ST exhibited greater and more rapid bactericidal activity than TobraDex against tobramycin- and methicillin-resistant strains5

TOBRADEX ST is more effective at killing resistant S aureus vs TobraDex5

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TOBRADEX ST has a faster kill rate of resistant S pneumoniae vs TobraDex (5 min vs 120 min)5

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

TOBRADEX ST offers half the dexamethasone concentration of TobraDex without sacrificing ocular tissue exposure5

  • 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.5,d
  • d Multicenter, double-blind, parallel-group, single-dose study of 987 patients receiving a single dose of TOBRADEX ST or TobraDex ophthalmic suspension.5

DELIVER THE TOBRADEX ST DIFFERENCE TO RESOLVE ACUTE FLARES

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

TOBRADEX ST has no therapeutic or generic equivalent

ST MATTERS—PRESCRIBE TOBRADEX® ST

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

For eligible patients with insurance coverage, and those on a plan that does not provide coverage for TOBRADEX ST (commercial or Medicare Part D/Medicare Advantage program) or are paying cash.*
  • *Source: Breakaway Partners LLC as of November 2021. Plan formularies will vary and are subject to change without notice. Please check directly with the health plan to determine the most up-to-date formulary information.

Patient Terms and Conditions:

Please visit MyEyeSavings.com to acquire and activate your Santen Copay Savings Program Card and present it along with a valid prescription to the pharmacy to participate in this savings program. If you have questions regarding your eligibility or benefits, or if you wish to discontinue your participation, call the Santen Copay Savings Program at 1.866.747.0976 (9 a.m. – 6 p.m. ET, Monday – Friday). For patients whose prescriptions are covered by commercial insurance, use of this card may reduce your copayment responsibility to as little as $39. For patients whose prescriptions are not covered by either commercial or Medicare Part D and Medicare Advantage insurance, use of this card may reduce your cost for prescriptions to as little as $39. This program is subject to overall maximum support amounts. This coupon is not valid for prescriptions paid for in part or full by Medicaid, Tricare, DOD, VA, or any state or federally funded program (excluding Medicare). Patients who have prescription drug coverage under Medicare Part D or Medicare Advantage may take advantage of this offer, provided that they acknowledge that by doing so they will not seek any prescription coverage or reimbursement from their insurer for the cost of prescriptions or report any amounts paid for prescriptions as part of their “true out-of-pocket expenses” under Medicare Part D or Medicare Advantage prescription drug plan. When you use this card, you are certifying that you understand the program rules, regulations, and terms and conditions, and that you have responded truthfully to questions when activating this card.

Pharmacist Instructions:

  • For commercially insured patients: Submit the claim to the primary Third Party Payer first, then submit the balance due to Change Healthcare as a Secondary Payer COB with patient responsibility amount and a valid Other Coverage Code (OCC 3,8). The patient is responsible for the first $39.00 and reimbursement for the balance, up to the program maximum, will be received from Change Healthcare.
  • For Cash and Medicare Part D insured patients opting out of their plan coverage and agreeing to the program terms: Submit this claim to Change Healthcare as Cash. A valid Other Coverage Code (OCC 0,1) is required. The patient is responsible for the first $39.00 and reimbursement for the balance, up to the program maximum, will be received from Change Healthcare.

Program Terms and Conditions:

The Santen Copay Savings Program card is not valid for use with any other prescription drug discount or cash cards for FLAREX®, TOBRADEX® ST, and/or ZERVIATE®. Claims submitted utilizing the program are subject to audit or validation.

When you process this card, you are certifying that you have read, understood, and are in compliance with the terms and conditions pertaining to this program. You are further certifying that you have not submitted and will not submit a claim for reimbursement under Medicare Part D or similar federal or state programs including any state medical pharmaceutical assistance program for this prescription.

Indication and Usage

TOBRADEX® ST (tobramycin and dexamethasone ophthalmic suspension) 0.3%/0.05% is a topical antibiotic 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.

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:

  • Intraocular Pressure (IOP) Increase—Prolonged use may result in glaucoma with damage to the optic nerve, and 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, then the patient should be re-evaluated.
  • Viral Infections—Use with a 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.
  • Vision Blurred—Vision may be temporarily blurred following dosing with TOBRADEX ST. Care should be exercised in operating machinery or driving a motor vehicle.
  • Risk of Contamination—Do not touch the dropper tip of the bottle to any surface, as this may contaminate the contents.
  • Contact Lens Use—TOBRADEX ST contains benzalkonium chloride, an antimicrobial preservative, which may be absorbed by soft contact lenses. Contact lenses should not be worn during the use of TOBRADEX ST.

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 IOP 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.

The following additional adverse reactions have been reported with the individual components below:

  • Aminoglycosides: Neurotoxicity, ototoxicity, and nephrotoxicity have occurred in patients receiving systemic aminoglycoside therapy. Aminoglycosides may aggravate muscle weakness in patients with known or suspected neuromuscular disorders, such as myasthenia gravis or Parkinson’s disease, because of their potential effect on neuromuscular function.
  • Dexamethasone: Cushing’s syndrome and adrenal suppression may occur after the use of dexamethasone in excess of the listed dosing instructions in predisposed patients, including children and patients treated with CYP3A4 inhibitors.

POSTMARKETING EXPERIENCE:

The following adverse reactions have been identified during postapproval use of TOBRADEX ST. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Additional adverse reactions identified from postapproval use include anaphylactic reaction and erythema multiforme.

Please see the full Prescribing Information.

CLARE=contact lens-induced acute red eye; IOP=intraocular pressure; MGD=meibomian gland dysfunction.

References: 1. 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. 2. Mand PM, Mannis MJ. What is the best treatment approach for severe blepharitis? Vis Pan-Am. 2014;13(3):67-69. 3. Baudouin C, Messmer EM, Aragona P, et al. Revisiting the vicious circle of dry eye disease: a focus on the pathophysiology of meibomian gland dysfunction. Br J Ophthalmol. 2016;100:300-306. 4. Amescua G, Akpek EK, Farid M, et al. Blepharitis Preferred Practice Pattern. Ophthalmology. 2019;126(1):P56-P93. 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. Prescribing information. Eyevance Pharmaceuticals LLC; 2022. 7. Patel A, Cholkar K, Agrahari V, et al. Ocular drug delivery systems: an overview. World J Pharmacol. 2013;2(2):47-64. 8. Rozi MF, Sabere ASM. A review on conventional and novel topical ocular drug delivery system. J Pharmacy. 2021;1(1):19-26. 9. Duxfield L, Sultana R, Wang R, et al. Ocular delivery systems for topical application of anti-infective agents. Drug Dev Ind Pharm. 2016;42(1):1-11. 10. U.S. Department of Health and Human Services, Food and Drug Administration. Approved drug products with therapeutic equivalence evaluations (Orange Book). 42nd ed. Washington, DC: U.S. Department of Health and Human Services, Food and Drug Administration; 2022.

Indication and Usage

TOBRADEX® ST (tobramycin and dexamethasone ophthalmic suspension) 0.3%/0.05% is a topical antibiotic 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.

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:

  • Intraocular Pressure (IOP) Increase—Prolonged use may result in glaucoma with damage to the optic nerve, and 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, then the patient should be re-evaluated.
  • Viral Infections—Use with a 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.
  • Vision Blurred—Vision may be temporarily blurred following dosing with TOBRADEX ST. Care should be exercised in operating machinery or driving a motor vehicle.
  • Risk of Contamination—Do not touch the dropper tip of the bottle to any surface, as this may contaminate the contents.
  • Contact Lens Use—TOBRADEX ST contains benzalkonium chloride, an antimicrobial preservative, which may be absorbed by soft contact lenses. Contact lenses should not be worn during the use of TOBRADEX ST.

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 IOP 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.

The following additional adverse reactions have been reported with the individual components below:

  • Aminoglycosides: Neurotoxicity, ototoxicity, and nephrotoxicity have occurred in patients receiving systemic aminoglycoside therapy. Aminoglycosides may aggravate muscle weakness in patients with known or suspected neuromuscular disorders, such as myasthenia gravis or Parkinson’s disease, because of their potential effect on neuromuscular function.
  • Dexamethasone: Cushing’s syndrome and adrenal suppression may occur after the use of dexamethasone in excess of the listed dosing instructions in predisposed patients, including children and patients treated with CYP3A4 inhibitors.

POSTMARKETING EXPERIENCE:

The following adverse reactions have been identified during postapproval use of TOBRADEX ST. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Additional adverse reactions identified from postapproval use include anaphylactic reaction and erythema multiforme.

Please see the full Prescribing Information.