In a recent press release, medical device and pharmaceutical manufacturer Glaukos Corporation announced results of the phase III (3) clinical trials for its iDose® TR implant device. Calling the results “robust and replicative,” company executives are poised to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for approval. Learn about their findings, and what they could mean for people living with glaucoma.*

What is iDose® TR?

A new glaucoma treatment, iDose TR is a titanium implantable device that provides continuous drug delivery of the medication travoprost as an alternative to eye drops. The iDose TR delivers a novel, highly potent formulation of travoprost through an implant injected directly into the white outer layer of the eyeball, or the sclera, using a minimally invasive injector system. 

What the researchers did

The pivotal phase III studies for iDose TR consisted of two (2) randomized and controlled double-blind clinical trials. 

• The trials tested the safety and effectiveness of the device against 0.5% timolol BID (twice-daily application). 
• Two groups received the iDose TR (one fast-release form, and one slow-release form), and a third group received topically-applied timolol applied.
• Both the slow- and fast-release devices were tested for lowering IOP in people with ocular hypertension—eye fluid pressure over 21 mmHg (millimeters of mercury)—or with open-angle glaucoma.

Both trials lasted three (3) months and enrolled 1,150 participants across 89 test sites.

• The first trial randomized 590 patients.
  • 200 were given slow-release iDose TR.
  • 197 were given fast-release iDose TR.
  • 103 were given timolol (control group).

• The second trial randomized 561 patients.
  • 183 were given slow-release iDose TR.
  • 185 were given fast-release iDose TR.
  • 193 were given timolol (control group).

What they found

After three months, both slow- and fast-release implants either kept pace with or outstripped timolol in terms of lowering IOP.

• In the first trial, slow-release iDose TR lowered IOP by 6.6 to 8.5 mmHg versus timolol at 6.6 to 7.7 mmHg.
• In the second trial, slow-release iDose TR lowered IOP by 6.7 to 8.4 mmHg versus timolol at 6.8 to 7.2 mmHg.

In both trials, 81% of participants who received slow-release iDose TR were able to stop all topical medications after one year. No serious adverse effects were observed with the implant.

What it means

In the press release, Glaukos chairman and chief executive officer Thomas Burns said that the trial results “powerfully reaffirm” the company’s view that iDose TR can be a transformative technology for improving glaucoma patient treatment.

“We believe,” he said, “there is an important unmet clinical need and strong appetite within the ophthalmic community for safe, effective and sustained dropless pharmaceutical alternatives to traditional topical medications.”

He added that the company now stands “ideally positioned” to submit an NDA to the FDA for a formal review and, they hope, approval of the device for widespread use.

*Hunter, E. (2022, September 20). Glaucoma Treatment Shows Positive Results in Phase 3 Trial. Pharmacy Times. https://www.pharmacytimes.com/view/glaucoma-treatment-shows-positive-results-in-phase-3-trial