Idose Tr

— THERAPEUTIC CATEGORIES —
  • Glaucoma
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Idose Tr Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Travoprost 75mcg; intracameral implant.

    Pharmacological Class

    Prostaglandin analogue.

    How Supplied

    Single-dose inserter—1

    Storage

    Store at 2°C to 25°C (36°F to 77°F). Do not freeze. 

    Manufacturer

    Glaukos Corporation

    Generic Availability

    NO

    Mechanism of Action

    Travoprost free acid, a prostaglandin analog is a selective FP prostanoid receptor agonist, which is believed to reduce IOP by increasing uveoscleral outflow. The exact mechanism of action is unknown.

    Idose Tr Indications

    Indications

    Reduction of elevated intraocular pressure in open-angle glaucoma or ocular hypertension.

    Idose Tr Dosage and Administration

    Adult

    See full labeling. Give as intracameral inj through a small, clear corneal incision. Do not readminister to an eye that has received prior iDose TR. 

    Children

    Not established.

    Idose Tr Contraindications

    Contraindications

    Ocular or periocular infections. Corneal endothelial dystrophy (eg, Fuch's Dystrophy, corneal guttatae). Prior corneal transplantation or endothelial cell transplants (eg, Descemet’s Stripping Automated Endothelial Keratoplasty). 

    Idose Tr Boxed Warnings

    Not Applicable

    Idose Tr Warnings/Precautions

    Warnings/Precautions

    Narrow iridocorneal angles (Shaffer grade <3) or other angle abnormalities (eg, peripheral anterior synechia, rubeosis iridis). Monitor routinely to confirm location of implant; remove if dislocated. Aphakia. Pseudophakia with torn posterior lens capsule. Risk factors for macular edema. Active intraocular inflammation (eg, uveitis). Monitor if increased iris pigmentation occurs. Endophthalmitis. Magnetic resonance imaging (MRI) conditional; see full labeling. Pregnancy. Nursing mothers.

    Idose Tr Pharmacokinetics

    See Literature

    Idose Tr Interactions

    Not Applicable

    Idose Tr Adverse Reactions

    Adverse Reactions

    Increased intraocular pressure, iritis, dry eye, visual field defects, eye pain, ocular hyperemia, reduced visual acuity; device dislocation, hypersensitivity.

    Idose Tr Clinical Trials

    Clinical Trials

    The safety and efficacy of iDose TR was based on 2 randomized, parallel-group, double-masked, controlled phase 3 trials (ClinicalTrials.gov Identifier: GC-010 [NCT03519386], GC–012 [NCT03868124]) in adult patients with open-angle glaucoma or ocular hypertension. Study participants were randomly assigned to receive either iDose TR containing travoprost 75mcg with different release rates or timolol maleate ophthalmic solution 0.5% twice daily. The primary endpoint for both studies was the change from baseline in diurnal IOP (as measured at 8am and 10am) over 3 months (day 10, week 6, and month 3).

    Findings showed that treatment with iDose TR demonstrated an IOP reduction of 6.6 to 8.4mmHg over the first 3 months compared with an IOP reduction of 6.5 to 7.7mmHg in the timolol arm. iDose TR was found to be noninferior to timolol in IOP reduction over the first 3 months, but did not demonstrate noninferiority over the following 9 months. Across both trials, 81% of patients who received iDose TR were completely free of IOP-lowering topical medications.

    Idose Tr Note

    Not Applicable

    Idose Tr Patient Counseling

    See Literature

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