iDose TR 75 ug/1
Travoprost Intracameral · IMPLANT · Glaukos Corporation
iDose TR is a implant containing travoprost intracameral at 75 ug/1, taken intracameral. Manufactured by Glaukos Corporation.
Key Facts
- Brand Name
- iDose TR
- Generic Name
- Travoprost Intracameral
- NDC Code (Product)
25357-100- Manufacturer
- Glaukos Corporation
- Strength
- 75 ug/1
- Dosage Form
- IMPLANT
- Route
- INTRACAMERAL
- Marketing Status
- Application #
- NDA218010
- Drug Class
- Prostaglandin Analog [EPC]
- Marketing Start
- 12/13/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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). 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 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For ophthalmic intracameral administration ( 2.1 ) The intracameral administration should be carried out under standard aseptic conditions ( 2.2 ) 2.1 General Dosing Information iDose TR is a travoprost delivery system consisting of a travoprost releasing implant pre-loaded in a sterile, single-dose inserter. iDose TR is administered intracamerally through a small, clear corneal incision and is anchored into the sclera at the iridocorneal angle. 2.2 Administration Instructions 1. The procedure must be carried out under aseptic conditions which include use of sterile gloves and a sterile drape. 2. The eye should be anesthetized using general, retrobulbar, peribulbar, or topical anesthesia per standard 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, with the 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 su…
Contraindications
4 CONTRAINDICATIONS Ocular or periocular infections ( 4.1 ) Corneal endothelial dystrophy ( 4.2 ) Prior corneal transplantation ( 4.3 ) Hypersensitivity ( 4.4 ) 4.1 Ocular or Periocular Infections iDose TR (travoprost intracameral implant) is contraindicated in patients with active or suspected ocular or 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 of the product .
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: 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 ( 5.6 )] Intraocular inflammation [see Warnings and Precautions ( 5.7 )] Pigmentation [see Warnings and Precautions ( 5.8 )] Endophthalmitis [see Warnings and Precautions ( 5.9 )] In controlled studies, the most common ocular adverse reactions reported in 2% to 6% of patients were increases in intraocular pressure, iritis, dry eye, and visual field defects ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Glaukos Corporation at 1-888-404-1644 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 and may not reflect the…
Frequently Asked Questions
What is iDose TR used for?
iDose TR contains Travoprost Intracameral. It is a implant taken intracameral. Consult your doctor for specific uses.
Is iDose TR a controlled substance?
iDose TR is not classified as a controlled substance by the DEA.
What is the generic name for iDose TR?
The generic name for iDose TR is Travoprost Intracameral. There are no other listed brand versions of Travoprost Intracameral.
What is the NDC code for iDose TR 75 ug/1?
The NDC (National Drug Code) for iDose TR 75 ug/1 is 25357-100, listed by Glaukos Corporation.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)