FDA Approves Labeling Update for iDose TR for Open-Angle Glaucoma and Ocular Hypertension

The US Food and Drug Administration (FDA) has approved a labeling supplement permitting repeat administration of iDose TR (travoprost intracameral implant) for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).¹

Announced on January 28, 2026, this update modifies prior labeling that limited use to a single administration and is based on accumulated clinical safety data, including corneal endothelial outcomes, submitted by the manufacturer.¹

Glaucoma remains a leading cause of irreversible blindness worldwide, with IOP reduction as the only proven modifiable risk factor.³ Prostaglandin analog eye drops are widely recommended as first-line therapy due to their efficacy and once-daily dosing.⁵ However, real-world adherence to topical therapy is suboptimal, with studies estimating that 30% to 50% of patients do not use drops as prescribed. Factors include ocular surface disease, difficulty with instillation, cost, and treatment fatigue.⁶

Procedural drug delivery approaches, including intracameral implants, aim to bypass adherence barriers while providing sustained IOP control. Until recently, these strategies were constrained by questions surrounding repeatability, reversibility, and long-term corneal safety—particularly endothelial cell loss, a known risk with intraocular devices and procedures.⁷

For clinicians managing chronic glaucoma, the labeling change addresses a practical limitation of long duration intracameral therapy: how to maintain sustained prostaglandin exposure beyond the life of an initial implant while preserving corneal safety. Repeat dosing may expand the role of procedural pharmacotherapy for patients who struggle with adherence or tolerability of topical medications, although long-term comparative effectiveness data remain limited.

iDose TR is a titanium-based intracameral implant that continuously elutes a proprietary, preservative-free formulation of travoprost into the anterior chamber via membrane-controlled diffusion. The device contains 75 µg of travoprost and is implanted through the trabecular meshwork into the scleral tissue. The FDA originally approved iDose TR in 2023 for a single administration to reduce IOP in adults with OAG or OHT.⁴

Travoprost is a prostaglandin F2α analog that lowers IOP by increasing uveoscleral outflow. Its efficacy and safety as a topical agent are well established. iDose TR represents an extension of this mechanism via continuous intraocular delivery rather than episodic topical dosing.⁸

The newly approved labeling supplement allows re-administration in patients who maintain a “healthy cornea,” defined by corneal endothelial cell density parameters outlined in the updated prescribing information. According to the new label, repeat administration requires removal of the original implant and intracameral placement of a new device under standard aseptic conditions.¹

The approval was supported by pooled corneal safety data from phase 3 pivotal trials and a phase 2b study, which followed patients for up to 3 years after implantation. In these studies, no clinically significant corneal endothelial cell loss was observed over time. The manufacturer also cited results from an “exchange” study evaluating removal of the original implant and placement of a second iDose TR, with 12 months of follow-up demonstrating acceptable safety and tolerability. As of this writing, peer-reviewed publication of the exchange trial data is limited, and detailed efficacy outcomes following re-administration have not been widely reported.^1,4

Across controlled studies of single administration, commonly reported ocular adverse reactions (2%–6%) included increased IOP, iritis, dry eye, ocular hyperemia, eye pain, visual field defects, and reduced visual acuity. Consistent with other prostaglandin analogs, increased iris pigmentation has been reported and may be permanent.²

In the phase 3 GC-010 and GC-012 trials, iDose TR demonstrated sustained IOP reduction comparable to topical timolol through 12 months, with durability extending beyond 24 months in extension analyses. These trials primarily evaluated a single implant, and while efficacy waned over time in some patients, corneal safety outcomes were favorable, supporting further investigation of repeat use.⁴

However, the labeling update does not establish superiority over topical therapy or other sustained-release options, nor does it define optimal timing for re-administration. Head-to-head comparisons with other long-acting approaches, such as bimatoprost intracameral implants, are lacking.⁹

Evidence supporting repeat administration is primarily safety-focused, with limited published data on long-term efficacy after reimplantation. Real-world outcomes, cost-effectiveness, and patient-reported measures will be critical to defining the role of repeat intracameral therapy in routine practice. Ongoing postmarketing surveillance and future comparative studies will be needed to clarify these questions.

References

1. Glaukos Corporation. Glaukos Announces US FDA Approval of NDA Supplement Allowing for Re-Administration of iDose TR. BusinessWire. January 28, 2026. Accessed January 28, 2026. https://www.businesswire.com/news/home/20260128062505/en/Glaukos-Announces-US-FDA-Approval-of-NDA-Supplement-Allowing-for-Re-Administration-of-iDose-TR

2. Glaukos Corporation. Glaukos Announces FDA Approval of iDose TR (travoprost intracameral implant). December 14, 2023. Accessed January 28, 2026. https://investors.glaukos.com/news/news-details/2023/Glaukos-Announces-FDA-Approval-of-iDoseTR-travoprost-intracameral-implant/default.aspx

3. Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040. Ophthalmology. 2014;121(11):2081-2090. doi:10.1016/j.ophtha.2014.05.013

4. Singh IP, Berdahl JP, Sarkisian SR, et al. Long-term safety and efficacy evaluation of Travoprost intracameral implant based on pooled analyses from two phase III trials. Drugs. 2024;84(10):1299-1311. doi:10.1007/s40265-024-02074-9

5. Prum BE Jr, Rosenberg LF, Gedde SJ, et al. Primary open-angle glaucoma preferred practice pattern. Ophthalmology. 2016;123(1):P41-P111. https://www.aaojournal.org/article/S0161-6420(15)01276-2/pdf

6. Newman-Casey PA, Robin AL, Blachley T, et al. The most common barriers to glaucoma medication adherence. Ophthalmology. 2015;122(7):1308-1316. doi:10.1016/j.ophtha.2015.03.026

7. Lass JH, Benetz BA, Gal RL, et al. Donor age and corneal endothelial cell loss 5 years after successful corneal transplantation. Ophthalmology. 2013;120(10):1949-1956. doi:10.1016/j.ophtha.2008.01.004

8. Netland PA, Gross RL, Peace JH, et al. Long-term efficacy and safety of travoprost compared with timolol in patients with open-angle glaucoma or ocular hypertension. Am J Ophthalmol. 2001;132(4):472-484. doi:10.1016/s0002-9394(01)01177-1

9. Lewis RA, Christie WC, Day DG, et al. Bimatoprost sustained-release implants for glaucoma therapy: 24-month results from a phase 1/2 clinical trial. Ophthalmology. 2017;124(12):1687-1694. doi:10.1007/s40265-019-01248-0