FDA approves NDA labeling supplement allowing re-administration of iDose TR

The US FDA has approved an NDA labeling supplement from Glaukos enabling the re-administration of iDose TR (travoprost intracameral implant) using a repeat treatment protocol.

According to the company, under the updated labeling for iDose TR, physicians may now re-administer iDose TR more than once in patients who maintain a healthy cornea, as defined by corneal endothelial cell density parameters.

iDose is a long-duration prostaglandin analog indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). It is implanted through the trabecular meshwork and back wall of Schlemm's canal, directly into scleral tissue. When implanted, the iDose continuously elutes into the anterior chamber via membrane-controlled diffusion 75 mcg of a novel, preservative-free, proprietary formulation of travoprost—allowing for 24/7 release of medication.

Thomas Burns, Glaukos chairman and CEO, commented on the FDA decision, saying, “[This] 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. 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.”

At the beginning of 2025, Glaukos released several positive clinical updates for its iDose sustained-release procedural pharmaceutical platform. In 36-month follow-up data of the company’s 2 phase 3 pivotal clinical trials, the company noted that iDose TR 75 mcg demonstrated sustained substantial IOP reductions. Furthermore, approximately 70% of iDose TR patients remained well-controlled on the same or fewer IOP-lowering topical medications at 36 months after a single administration, versus 58% of timolol control subjects.²

The iDose TR was first approved by the FDA for use in the reduction of IOP in patients with OHT or OAG in December 2023 and was based on results from 2 prospective, randomized, multicenter, double-masked, Phase 3 pivotal trials (GC-010 and GC-012).

Additionally, in October 2025, the FDA approved Glaukos’ new drug application for its topical drug therapy (Epioxa HD/Epioxa) for keratoconus—making it the first FDA-approved corneal cross-linking treatment that is incision-free and does not require removing the corneal epithelium, noted the company.

Looking ahead

In an interview with Joel Schuman, MD, of Wills Eye Hospital in Philadelphia, Pennsylvania, he noted that sustained release and controlled drug delivery approaches were most likely going to grow in number.³

“The FDA has already approved [these implants], and I think that we’re going to see more devices like that,” Schuman said.

He noted that the pipeline for these therapies is continuing to mature, with additional devices under development, while also acknowledging that adoption will be influenced by factors such as cost, safety signals, patient acceptance, and workflow considerations.

References:

1. Glaukos Announces US FDA Approval of NDA Supplement Allowing for Re-Administration of iDose TR. Published January 28, 2026. Accessed January 28, 2026. https://investors.glaukos.com/news/news-details/2026/Glaukos-Announces-US-FDA-Approval-of-NDA-Supplement-Allowing-for-Re-Administration-of-iDose-TR/default.aspx

2. Harp MD. Glaukos announces several positive clinical updates for its iDose platform. Published January 20, 2025. Accessed January 28, 2026. https://www.ophthalmologytimes.com/view/glaukos-announces-several-positive-clinical-updates-for-its-idose-platform

3. Schuman JS. Smith OU. Stevenson S. Glaucoma innovation: Eight themes to watch in 2026. Published January 9, 2026. Accessed January 28, 2026. https://www.ophthalmologytimes.com/view/glaucoma-innovation-eight-themes-to-watch-in-2026