Glaukos Corporation has received FDA approval for a new drug application (NDA) labeling supplement of iDose TR (travoprost intracameral implant) 75 mcg.
iDose TR? That’s been on the market for a few years, right?
Correct. The biocompatible titanium implant was first granted regulatory approval in 2023 before launching to the U.S. commercial market in early 2024.
Give us a little rundown on it.
- Its purpose: Administered during micro-invasive glaucoma procedures
- See its full prescribing information and check out its permanent J-code
- Click here for which glaucoma patients are the ideal candidates
- The device: Consists of a proprietary, preservative-free formulation of travoprost preloaded in a single-dose insert
- Why use travoprost: This prostaglandin analog is indicated for the reduction of intraocular pressure (IOP) in patients with ocular hypertension (OHT) or open-angle glaucoma (OAG)
- How it works: The drug is continuously released in micro-amounts inside the anterior chamber over a 1-year duration—after which the implant can be retrieved and replaced with another implant if medically necessary.
Now explain the basics of an NDA labeling supplement.
In general: This is a submission to the FDA requesting approval to adjust the PI or packaging of an already-approved drug.
These updates may be made to reflect new safety data, indications, or manufacturing changes to ensure the drug is still compliant with federal regulations.
- Get a closer look at the entire post-approval process.
And in the case of the iDose TR?
This labeling supplement approval allows the implant to be re-administered under a repeat treatment protocol.
More specifically: Physicians can now re-administer the iDose TR more than once in “patients who maintain a healthy cornea, as defined by corneal endothelial cell density (ECD) parameters," according to Glaukos.
Explain this re-administration process.
Based on the iDose TR’s updated PI: Physicians are advised to perform specular microscopy to evaluate a patient’s corneal endothelium prior to re-administering the implant.
Dosage modifications should be made if the following adverse reactions occur:
- Ocular or periocular infections
- Prior iDose TR device dislocation
- Central corneal endothelial cell loss of 10% or greater from pre-administration baseline
- This is adjusted for age-related 1% loss per year and for a 10% loss following an anterior segment surgical procedure (such as cataract surgery)
And what dosage modifications are advised with any of these reactions?
The PI advises that re-administration should be withheld.
Got it. So if a patient is in the clear for re-administration, how does that work?
Head over to Section 2.4 of the iDose TR’s updated PI for a step-by-step rundown.
And how often can the implant be re-administered?
No more than once per year.
Noted. So what clinical data support this updated labeling?
The company noted that an accumulation of clinical evidence—ranging from phase 2 and 3 studies to an exchange trial—supported the safety and tolerability of repeat use of the implant.
- In phase 2b/3 studies:
- A favorable long-term corneal safety profile was demonstrated, with “no clinically significant” CEC loss observed over a 3-year period
- In an iDose TR exchange trial:
- A second iDose TR administration and subsequent removal of the original implant were demonstrated as safe and well-tolerated
- That second implant also demonstrated a favorable safety profile over a 12-month period.
And the significance?
Per Glaukos Chairman and CEO Thomas Burns, the updated labeling is designed to benefit both patients and physicians:
- For patients: Expand access for those who may benefit from repeat treatment
- For physicians: Enable greater flexibility in managing their patients over time
He added that the approval reinforces the iDose TR as a “safe, effective, and sustained procedural pharmaceutical (alternative) to traditional topical medications.”