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Shatter Expectations 

Clinically Proven with Foundational IOP Control

In two pivotal trials, iDose TR achieved the pre-specified primary efficacy endpoint (non-inferiority to topical timolol through 3 months).1

 Phase 3 Clinical Trials graph of the Range of IOP Reductions Through 3 Months.

Non-inferiority of iDose TR to timolol was established if the upper limit of the two-sided 95% confidence interval for the difference in the mean of change from baseline in IOP was <1.5 mmHg at each of the six post-baseline timepoints and was < 1 mmHg at half or more of the six post-baseline timepoints.

PHASE 3 STUDY DESIGN

To evaluate iDose TR efficacy and safety in patients with ocular hypertension and open-angle glaucoma. Two identically-designed Phase 3, parallel-group, double-masked, randomized, prospective, sham-controlled trials compared iDose TR to topical timolol (0.5%) BID. N=1150; 89 trial sites1*

PRIMARY ENDPOINT

Change from baseline in diurnal IOP (vs timolol) through 3 months postoperative.1**

Enduring Control at 12 Months†

  • 81%of iDose TR subjects were completely free of IOP-lowering topical medications
    (23% were originally on 2+ medications pre-trial)1

ABOUT
iDOSE TR

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iDOSE TR
SAFETY

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1. iDose TR Phase 3 Clinical Trials, data on file, Glaukos Corporation.
*Inclusion Criteria: Patients 18 years or older; diagnosed with open-angle glaucoma (POAG, PXG or PG) or ocular hypertension; C/D ratio ≤ 0.8; zero to three preoperative ocular hypotensive medications; BSCVA of 20/80 or better.
** Change from time-matched baseline in IOP at 8AM and 10AM at Day 10, Week 6 and Month 3.
† iDose TR clinical results shown represent the approved and commercially marketed version; identified as the “slow-eluting implant arm” in the pivotal trials.

Important Safety Information

Dosage And Administration

For ophthalmic intracameral administration. The intracameral administration should be carried out under standard aseptic conditions.

Contraindications

iDose TR is contraindicated in patients with active or suspected ocular or periocular infections, patients with corneal endothelial cell dystrophy (e.g., Fuch’s Dystrophy, corneal guttatae), patients with prior corneal transplantation, or endothelial cell transplants (e.g., Descemet’s Stripping Automated Endothelial Keratoplasty [DSAEK]), patients with hypersensitivity to travoprost or to any other components of the product.

Warnings And Precautions

iDose TR should be used with caution in patients with narrow angles or other angle abnormalities. Monitor patients routinely to confirm the location of the iDose TR at the site of administration. Increased pigmentation of the iris can occur. Iris pigmentation is likely to be permanent.

Adverse Reactions

In controlled studies, the most common ocular adverse reactions reported in 2% to 6% of patients were increases in intraocular pressure, iritis, dry eye, visual field defects, eye pain, ocular hyperaemia, and reduced visual acuity.

Indications And Usage

iDose TR (travoprost intracameral implant) is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Please see full Prescribing Information.

You are encouraged to report all side effects to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

You may also call Glaukos at 1-888-404-1644.

The information contained in this site is intended for US healthcare professionals only

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