HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed
to use iDose® TR safely and effectively. See full prescribing
information for iDose® TR.
iDose® TR (travoprost intracameral implant), forintracameral administration
Initial U.S. Approval: 2001---------------INDICATIONS AND USAGE----------------iDose® TR is a prostaglandin analog indicated for the
reduction of intraocular pressure (IOP) in patients with
open-angle glaucoma (OAG) or ocular hypertension (OHT)(1)• Corneal endothelial dystrophy (4.2)• Prior corneal transplantation (4.3)• Hypersensitivity (4.4)---------------WARNINGS AND PRECAUTIONS--------• Iridocorneal Angles: iDose TR should be used with caution
in patients with narrow angles or other angle abnormalities(5.1)• Device Dislocation: Monitor patients routinely to confirm
the location of the iDose TR at the site of administration(5.2)• Pigmentation: Increased pigmentation of the iris can occur.
Iris pigmentation is likely to be permanent (5.5)-------------DOSAGE AND ADMINISTRATION---------• For ophthalmic intracameral administration (2.1)• The intracameral administration should be carried out
under standard aseptic conditions (2.2)-------------------ADVERSE REACTIONS------------------In controlled studies, the most common ocular adverse
reactions reported in 2% to 6% of patients were increases inintraocular pressure, iritis, dry eye, and visual field defects(6.1)---------DOSAGE FORMS AND STRENGTHS----------Intracameral implant containing 75 mcg travoprost, pre-loaded
in a single-dose inserter (3)To report SUSPECTED ADVERSE REACTIONS, contact
Glaukos Corporation at 1-888-404-1644 or FDA at 1-800FDA-1088 or www.fda.gov/medwatch.

-------------------CONTRAINDICATIONS-----------------• Ocular or periocular infections (4.1)

Revised: 12/2023

FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 General Dosing Information
2.2 Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Ocular or Periocular Infections
4.2 Corneal Endothelial Dystrophy
4.3 Prior Corneal Transplantation
4.4 Hypersensitivity
5 WARNINGS AND PRECAUTIONS
5.1 Iridocorneal Angles
5.2 Device Dislocation
5.3 Macular Edema
5.4 Intraocular Inflammation
5.5 Pigmentation
5.6 Endophthalmitis
5.7 Magnetic Resonance Imaging (MRI) Conditional

6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION* Sections or subsections omitted from the full prescribing
information are not listed.

FULL PRESCRIBING INFORMATION
1

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).
2DOSAGE AND ADMINISTRATION

2.1

General Dosing Information

iDose TR is a travoprost delivery system consisting of a travoprost releasing implant pre-loaded in asterile, single-dose inserter. iDose TR is administered intracamerally through a small, clear corneal
incision and is anchored into the sclera at the iridocorneal angle. iDose TR should not be readministered
to an eye that received a prior iDose TR.
2.2
Administration
1. The procedure must be carried out under aseptic conditions which include use of sterile gloves and asterile drape.
2. The eye should be anesthetized using general, retrobulbar, peribulbar, or topical anesthesia perstandard operating room procedures.
3. The iDose TR implantation procedure must be performed under magnification that allows clear
visualization of the anterior chamber angle and angle structures including trabecular meshwork, withthe patient’s head in a stabilized position. The pupil should not be dilated prior to the procedure.
4. An intracameral miotic can be injected to deepen the angle prior to insertion of the iDose TR.
5. It is recommended that the implant surgery be performed from the temporal side, using a temporal
clear corneal incision. The implant will be implanted through the angle and the trabecular meshwork
into the sclera on the nasal side.
6. Remove the barrier pouch from the carton and examine for damage. Open the barrier pouch, discard
the oxygen scavenger packet, and remove the blister tray with Tyvek® lid. Open the Tyvek lid
containing the iDose TR pre-loaded inserter and present to the surgeon. The iDose TR implant andsingle-dose inserter should be handled in the sterile field. Caution: Do not use the iDose TR if the
Tyvek lid has been opened or the packaging appears damaged.
7. Prepare for gonioscopy by turning the patient’s head away from the surgeon by approximately 15° to
25° and tilt the scope toward the surgeon by approximately 35°. The total combined angle should beapproximately 50° to 60°.
8. Place a small amount of viscoelastic on the cornea. Position the gonioprism on the cornea using lighttouch gonioscopy. Adjust the microscope to locate and focus on the trabecular meshwork.
9. Inspect the angle with a gonioprism to ensure that a good view of all angle structures is available atthe nasal implant location.
10. Hold the single-dose inserter as shown in Figure 1 with your index finger comfortably on the implantrelease button.

Figure 1

11. Perform a detailed inspection of the tip of the sterile inserter under magnification to ensure that theiDose TR implant is present (Figure 2)
Figure 2

12. Create a clear corneal incision of approximately 2.4 mm at the temporal limbus location using an
instrument of the surgeon’s choice.
13. Add a cohesive viscoelastic to the anterior chamber as needed to form the anterior chamber andimprove visualization of the angle. Be careful not to overinflate.

14. Insertion of the implant:a. When ready for implantation, remove the safety clip which holds the release button in place bysqueezing and rocking the clip backwards (see Figure 2). Place finger on the release button toensure it remains in the forward position and does not prematurely release the implant.
b. To smoothly enter the anterior chamber, slide the inserter tip with implant “side to side” in theincision.
c. Advance to the pupillary margin and ensure there is sufficient cohesive viscoelastic on the cornea
before replacing the gonioprism onto the cornea.
d. Take care to avoid contact with the lens or cornea.
e. Advance to the anterior chamber angle and approach the trabecular meshwork (see Figure 3).
Figure 3

f. Press the implant directly through the trabecular meshwork, compressing the tissue until theimplant anchor securely penetrates the sclera through the back wall of Schlemm’s canal. The baseof the implant reservoir should be firmly in contact with and compressing the trabecularmeshwork.
g. Once the anchor of the implant is securely embedded in sclera, pause for the tissue to relax.
Carefully slide the implant release button backwards to open the inserter tip with grasper andrelease the implant from the inserter (Figure 4a). Ensuring the implant has released from theinserter grasper, slowly remove the inserter straight back (Figure 4b). Avoid pulling the implantout of position.

Figure 4a

Figure 4bh. Apply slight pressure to the sides of the implant with the tip of the inserter to ensure the implant isfully anchored into scleral tissue. Note: If for any reason the implant appears loose or disengaged
from the scleral tissue after the initial implantation, slide the implant release button back to fully
open the graspers. Position the graspers between the ribs on the implant and regrasp the body ofthe implant between the ribs by pushing the release button forward and re-implant a minimum of½ clock hour to either side. Do not re-implant at the same location.
i. Withdraw the inserter from the eye.
15. Location of iDose TR in Trabecular Meshwork
a. Perform a high-magnification examination to confirm that the implant is in proper position (i.e.,
the proximal end rests in the anterior chamber with an unobstructed membrane) (see Figure 5) andsecurely attached with the anchor thoroughly embedded in the sclera.

Figure 5b. It is normal for an edge of the implant to make contact with the iris. Note: In a normal iris (noviscoelastic in the anterior chamber and non-constricted pupil), the iris may obstruct the view of a
portion of the cap of the implant.
c. Irrigate and aspirate the anterior chamber with balanced salt solution to remove all viscoelastic.
Press down on the posterior edge of the incision as needed to facilitate complete removal ofviscoelastic.
d. Inflate the anterior chamber with saline solution as needed to achieve physiologic pressure.
3

DOSAGE FORMS AND STRENGTHSIntracameral implant containing 75 mcg travoprost, pre-loaded in a single-dose inserter.
4

CONTRAINDICATIONS

4.1

Ocular or Periocular Infections

iDose TR (travoprost intracameral implant) is contraindicated in patients with active or suspected ocularor periocular infections.
4.2

Corneal Endothelial Dystrophy

iDose TR is contraindicated in patients with corneal endothelial cell dystrophy (e.g., Fuch’s Dystrophy,
corneal guttatae).
4.3

Prior Corneal Transplantation

iDose TR is contraindicated in patients with prior corneal transplantation, or endothelial cell transplants(e.g., Descemet’s Stripping Automated Endothelial Keratoplasty [DSAEK]).
4.4

Hypersensitivity

iDose TR is contraindicated in patients with hypersensitivity to travoprost or to any other components ofthe product .

5

WARNINGS AND PRECAUTIONS

5.1

Iridocorneal Angles

iDose TR should be used with caution in patients with narrow iridocorneal angles (Shaffer grade < 3) orother angle abnormalities (e.g., peripheral anterior synechia, rubeosis iridis) that could impair proper
placement of iDose TR at the planned implantation site.
5.2

Device Dislocation

Dislocation of the iDose TR has been observed in clinical trials. Patients should be monitored routinely toconfirm the location of the iDose TR at the site of administration. If the iDose TR implant becomes
dislocated, it should be surgically removed.
5.3

Macular Edema

Macular edema, including cystoid macular edema, has been reported during treatment with ophthalmic
travoprost, including iDose TR intracameral implant. iDose TR should be used with caution in aphakic
patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors
for macular edema.
5.4

Intraocular Inflammation

Prostaglandin analogs, including iDose TR, have been reported to cause intraocular inflammation.
iDose TR should be used with caution in patients with active intraocular inflammation (e.g., uveitis)
because the inflammation may be exacerbated.
5.5

Pigmentation

Topical ophthalmic travoprost has been reported to cause increased pigmentation to pigmented tissues.
Pigmentation is expected to increase as long as travoprost is administered. The pigmentation change isdue to increased melanin content in the melanocytes rather than to an increase in the number ofmelanocytes. After discontinuation of travoprost, pigmentation of the iris is likely to be permanent. The
long-term effects of increased pigmentation are not known.
Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation
around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of theiris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. While
treatment with travoprost can be continued in patients who develop noticeably increased iris
pigmentation, these patients should be examined regularly.
5.6

Endophthalmitis

Intraocular surgical procedures and injections have been associated with endophthalmitis. Proper aseptic
technique must always be used with administering iDose TR, and patients should be monitored following
the administration.
5.7

Magnetic Resonance Imaging (MRI) Conditional

iDose TR is MR Conditional. Patients should be informed that the implant is MR Conditional (as notedon their Patient ID card). If the patient requires magnetic resonance imaging (MRI), they should informtheir healthcare provider that they have an iDose TR implanted in their eye.
A patient with the iDose TR may be safely scanned under the following conditions. Failure to follow
these conditions may result in injury to the patient.

Parameter
Nominal Values of Static
Magnetic Field (T)Maximum Spatial Field
Gradient(T/m and gauss/cm)
Type of RF Excitation
Transmit RF CoilInformation
Operating Mode of MR
SystemMaximum Whole Body
Averaged SAR
Maximum Head SAR
Limits on Scan Duration

MR Image Artifact

6

Condition of Use / Information
3.0 T or less
40-T/m (4,000-gauss/cm)

Circularly Polarized (CP) (i.e., Quadrature-Transmission)
Any transmit RF coil may be used
Normal Operating Mode
2-W/kg (Normal Operating Mode)
3.2-W/kg (Normal Operating Mode)
Whole body averaged SAR of 2-W/kg for 60 minutes of continuous
RF exposure (i.e., per pulse sequence or back-to-backsequences/series without breaks)
The presence of this implant produces an imaging artifact. Therefore,
carefully select pulse sequence parameters if the implant is located in
the area of interest.

ADVERSE REACTIONS

The following adverse reactions are described elsewhere in the labeling:

6.1•

Ocular or periocular infections [see Contraindications (4.1)]•

Corneal endothelial dystrophy [see Contraindications (4.2)]•

Prior corneal transplantation [see Contraindications (4.3)]•

Hypersensitivity [see Contraindications (4.4)]•

Device dislocation [see Warnings and Precautions (5.2)]•

Macular edema [see Warnings and Precautions (5.3)]•

Intraocular inflammation [see Warnings and Precautions (5.4)]•

Pigmentation [see Warnings and Precautions (5.5)]•

Endophthalmitis [see Warnings and Precautions (5.6)]
Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in
the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug andmay not reflect the rates observed in practice.
The following adverse events rates are derived from three randomized, double-masked clinical trials inwhich 868 patients with open angle glaucoma (OAG) or ocular hypertension (OHT) received an iDose TR
and were followed for one year. The most commonly reported ocular adverse reactions (2% to 6%) wereincreases in intraocular pressure, iritis, dry eye, visual field defects, eye pain, ocular hyperaemia, andreduced visual acuity. Ocular adverse reactions reported in less than 2% of patients were conjunctival

hemorrhage, photophobia, punctate keratitis, blepharitis, eye irritation, corneal abrasion, device
dislocation, vitreous detachment, and foreign body sensation in eyes.
8

USE IN SPECIFIC POPULATIONS

8.1

Pregnancy

Risk Summary
There are no adequate and well-controlled studies of iDose TR (travoprost intracameral implant)
administration in pregnant women to inform a drug-associated risk. Subcutaneous administration of
travoprost to pregnant mice and rats throughout the period of organogenesis produced embryo-fetal
lethality, spontaneous abortion, and premature delivery at potentially clinically relevant doses.
Advise pregnant women of a potential risk to a fetus. iDose TR should be administered during pregnancy
only if the potential benefit justifies the potential risk to the fetus.
Data
Animal Data
An embryo-fetal development study was conducted in pregnant rats administered travoprost once daily atdoses up to 10 mcg/kg by subcutaneous injection from gestation day (GD) 6 to 17, to target the period oforganogenesis. At 10 mcg/kg, 116 times the maximum human ocular dose (MHOD) of 1 implant per eye,based on body surface area (BSA), assuming sustained travoprost release from the implant for 6 months
or 0.0139 mcg/kg/day, travoprost was teratogenic in rats, evidenced by an increase in the incidence ofskeletal malformations as well as external and visceral malformations, including fused sternebrae, domed
head and hydrocephaly. Travoprost caused post-implantation loss at 10 mcg/kg. The fetal no observed
adverse effect level (NOAEL) was 3 mcg/kg (34.5 times the maximum human ocular dose (MHOD) of 1
implant per eye, based on BSA).
An embryo-fetal development study was conducted in pregnant mice administered travoprost once daily
by subcutaneous injection at doses up to 1 mcg/kg from GD 6 to 16, to target the period of organogenesis.
Travoprost induced an increase in post-implantation losses and a decrease in fetal viability in mice at
subcutaneous doses > 0.3 mcg/kg. The fetal NOAEL was 0.3 mcg/kg (1.7 times the MHOD based on
BSA). The maternal NOAEL was 1 mcg/kg (5.8 times the MHOD based on BSA).
Pre/postnatal development studies were conducted in rats administered travoprost once daily by
subcutaneous injection from GD 7 (early embryonic period) to postnatal Day 21 (end of lactation period).
At doses of greater than or equal to 0.12 mcg/kg/day (1.4 times the MHOD based on BSA), the incidenceof post-natal mortality was increased, and neonatal body weight was decreased. Neonatal development
was also affected, evidenced by delayed eye opening, pinna detachment and preputial separation, and by
decreased motor activity.
8.2

Lactation

Risk Summary
There are no data on the effects of travoprost on the breastfed child or milk production. It is not known if
travoprost is present in human milk following ophthalmic administration. The developmental and healthbenefits of breastfeeding should be considered, along with the mother’s clinical need for iDose TR andany potential adverse effects on the breast-fed child from iDose TR.
8.4

Pediatric Use

The safety and effectiveness of iDose TR have not been established in pediatric patients.

8.5

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and other adultpatients.
11

DESCRIPTION

iDose TR (travoprost intracameral implant) is a sterile intracameral implant containing 75 mcg oftravoprost. The intracameral implant consists of a titanium implant reservoir with a membrane controllingthe sustained release of travoprost. The sterile implant is pre-loaded in a sterile single-dose inserter tofacilitate insertion directly through the trabecular meshwork of the anterior chamber angle into the sclera.
Travoprost is a prostaglandin analog. Its chemical name is 5-heptenoic acid, 7-[(1R,2R,3R,5S)-3,5dihydroxy-2-[(1E,3R)-3-hydroxy-4-[3-(trifluoromethyl)phenoxy]-1-buten-1-yl]cyclopentyl]-, 1methylethyl ester, (5Z)-. Travoprost has a molecular formula of C26H35F3O6 and a molecular weight of
500.55 g/mol.
The chemical structure of travoprost is:

Travoprost is a clear, colorless to slightly yellow oil that is very soluble in acetonitrile, methanol, octanol,and chloroform. It is practically insoluble in water.
12

CLINICAL PHARMACOLOGY

12.1

Mechanism of Action

Travoprost free acid, a prostaglandin analog is a selective FP prostanoid receptor agonist, which isbelieved to reduce IOP by increasing uveoscleral outflow. The exact mechanism of action is unknown at
this time.
12.3

Pharmacokinetics

Travoprost, an isopropyl ester prodrug, is hydrolyzed by esterases in the cornea and other intraocular
tissues to its biologically active free acid. Systemically, travoprost free acid is metabolized to inactive
metabolites via beta-oxidation of the α (carboxylic acid) chain to give the 1,2-dinor and 1,2,3,4-tetranor
analogs, via oxidation of the 15-hydroxyl moiety, as well as via reduction of the 13, 14 double bond.
Data from a pharmacokinetic study of 105 subjects evaluating two models of the travoprost intracameral
implant with different elution rates have shown that the plasma concentrations of travoprost free acid are
below 10 pg/mL (the quantitation limit of the assay, LLOQ) in all subjects at day 10, week 12 and month
12 following administration of iDose TR.

13

NONCLINICAL TOXICOLOGY

13.1

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis
Two-year carcinogenicity studies in mice and rats at subcutaneous doses of 10, 30, or 100 mcg/kg/day did
not show any evidence of carcinogenic potential. However, at 100 mcg/kg/day, male rats were only
treated for 82 weeks, and the maximum tolerated dose (MTD) was not reached in the mouse study. The
high dose (100 mcg/kg) represents > 500 times the MHOD based on BSA.
Mutagenesis
Travoprost was not mutagenic in the Ames test, mouse micronucleus test or rat chromosome aberration
assay. A slight increase in the mutant frequency was observed in one of two mouse lymphoma assays in
the presence of rat S-9 activation enzymes.
Fertility
Travoprost did not affect mating or fertility indices in male or female rats at subcutaneous doses up to
10 mcg/kg/day (116 times the MHOD based on BSA) At 10 mcg/kg/day (116 times the MHOD based on
BSA), the mean number of corpora lutea was reduced, and the post-implantation losses were increased.
These effects were not observed at 3 mcg/kg/day (34.5 times the MHOD based on BSA).
14

CLINICAL STUDIES

iDose TR was evaluated in two multicenter, 12-month, randomized, parallel-group, double-masked,
controlled clinical trials in patients with OAG or OHT. In both trials (GC-010, NCT03519386, and GC012, NCT03868124), iDose TR was compared to twice-daily topical administration of timolol maleate
ophthalmic solution, 0.5%. In the first 3 months following administration, iDose TR demonstrated an IOP
change from baseline of -6.6 to -8.4 mmHg in the study eye of patients with a mean baseline IOP of
24 mmHg (see Figure 6).
Figure 6:

Change from Baseline in Study Eye IOP (mmHg) and Treatment Difference

Study GC-010

Study GC-012

iDose TR demonstrated non-inferiority to timolol ophthalmic solution in IOP reduction during the first
3 months. Subsequently, iDose TR did not demonstrate non-inferiority over the next 9 months.
16

HOW SUPPLIED/STORAGE AND HANDLING

iDose TR (travoprost intracameral implant) (NDC 25357-100-01) is provided sterile and pre-loaded in asterile, single-dose inserter that is packaged in a blister tray sealed with a Tyvek lid. Implants areindividually serialized and the serial number is provided on the tray lid.
The tray is sealed inside of a transparent plastic pouch along with an oxygen scavenger packet, which is
packaged inside a unit carton. Tamper evidence is provided by a seal on both ends of the carton.
Storage:
Store at 2°C to 25°C (36°F to 77°F). Do not freeze.
17

PATIENT COUNSELING INFORMATION

Intraocular Inflammation or Endophthalmitis
Advise patients about the potential risk for complications including, but not limited to, the development of
intraocular inflammation or endophthalmitis [see Warnings and Precautions (5.3, 5.4, 5.6)].
Potential for Pigmentation
Advise patients about the potential for increased brown pigmentation of the iris, which may be permanent[see Warnings and Precautions (5.5)].
MR Conditional
Advise patients that the implant is MR Conditional (as noted on their Patient ID card), and that if theyrequire magnetic resonance imaging (MRI), they should inform their healthcare provider that they haveiDose TR implanted in their eye [see Warnings and Precautions (5.7)].

When to Seek Physician Advice
Advise patients that if the eye becomes red, sensitive to light, painful, or develops a change in vision, theyshould seek immediate care from an ophthalmologist [see Warnings and Precautions (5.2, 5.4, 5.6)].
Symbols that are included in the labeling of this product.
SymbolDefinition
Catalogue/Model Number

Serial Number

Lot Number
Do not re-use

Use-by date (year-month)yyyy-mm
Do not resterilize

See package insert for Full
Prescribing Information
Temperature limit

Sterilized by Gamma Irradiation

RX Only

For prescription use only
Do not use if package isdamagedMR Conditional

Manufactured by Glaukos Corp., 229 Avenida Fabricante, San Clemente, CA 92672© 2023 Glaukos. All rights reserved.
All trademarks are the property of their respective owners.
Patented. U.S. Patent No. 10,206,813 and U.S. Patent No. 11,426,306.