January 29, 2026
1 min read
Key takeaways:
- iDose TR may be readministered if the patient has a healthy cornea.
- A second implant demonstrated safety over a 12-month evaluation period.
Editor’s note: This is a developing news story. Please check back soon for updates.
The FDA approved a new drug application labeling supplement that allows readministration of iDose TR with a repeat treatment protocol, according to a press release from Glaukos.
A second implant demonstrated safety over a 12-month evaluation period.
With the updated labeling, iDose TR (travoprost intracameral implant) may be readministered more than once in patients with corneal endothelial cell density parameters that demonstrate a healthy cornea.
The decision is supported by positive data from the iDose TR exchange trial, which showed the safety and tolerability of a second administration of the implant as well as the removal of the original implant. The second implant demonstrated safety over a 12-month evaluation period, according to the release, while phase 3 and phase 2b studies showed no clinically significant corneal endothelial cell loss over 3 years.
“We are pleased to announce this important labeling enhancement for iDose TR, which should help expand access for patients who may benefit from repeat treatment and provide physicians with greater flexibility in managing their glaucoma patients over time,” Thomas Burns, chairman and CEO of Glaukos, said in the release. “This approval further validates iDose TR’s established and proven safety profile and reinforces its leading position in addressing the strong and growing demand within the ophthalmic community for safe, effective and sustained procedural pharmaceutical alternatives to traditional topical medications.”
As Healio previously reported, iDose TR implantation in combination with cataract surgery showed reduced IOP with no significant safety concerns at 12 months.
Ask a clinical question and tap into Healio AI’s knowledge base.
- PubMed, enrolling/recruiting trials, guidelines
- Clinical Guidance, Healio CME, FDA news
- Healio’s exclusive daily news coverage of clinical data
<
Leave a Reply