Glaukos Corporation recently announced positive topline results from a phase 4 trial evaluating iDose TR (travoprost intracameral implant) 75 mcg administered with cataract surgery compared to cataract surgery alone in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
First up: the iDose TR.
The biocompatible titanium implant is a first-of-its-kind, long-duration, intracameral procedural pharmaceutical therapy designed to continuously deliver 24/7 therapeutic levels of a proprietary formulation of travoprost inside the eye.
- The duration: up to 3 years.
The device was first granted regulatory approval in 2023 before launching to the U.S. commercial market in early 2024.
Let’s get 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 OHT or OAG
And how does it work?
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.
Also worth noting: Earlier this year Glaukos received FDA approval for a new drug application (NDA) labeling supplement, allowing the implant to be re-administered under a repeat treatment protocol.
Now talk about this phase 4 trial.
As we mentioned, the prospective, multicenter, randomized, double-masked, parallel-group clinical trial (GLK-101-04; NCT06848946) is evaluating the efficacy and safety of iDose TR in combination with cataract surgery compared to cataract surgery alone in adults with OAG or OHT.
Its design: randomized 149 study eyes:
- 74 eyes assigned to the iDose TR implantation and cataract surgery cohort
- 75 eyes assigned to the cataract surgery alone arm
The primary outcome measure: Change from baseline in mean diurnal IOP at Month 3.
Moving on to the findings …
The study achieved its primary goal, with the iDose TR demonstrating statistically significant superiority in the reduction of mean diurnal IOP when administered in conjunction with cataract surgery compared to cataract surgery alone.
By Month 3, participants undergoing cataract surgery and administration of iDose TR achieved a mean diurnal IOP reduction of 11.1 mmHg from baseline.
- Conversely: Those undergoing cataract surgery alone experienced a 7.4 mmHg IOP reduction, demonstrating statistically significant superiority with a clinically meaningful incremental treatment effect of 3.6 mmHg (p<0.0001).
Plus: iDose TR demonstrated statistically significant superiority across all pre-specified secondary responder analyses, further supporting the consistency and robustness of the treatment effect observed in the study.
Do we know what those pre-specified secondary responder analyses included?
No, those details have not been shared publicly (by the company or the study’s ClinicalTrials.gov page.
How about safety results?
The device also demonstrated a favorable safety profile through 3 months, with no treated-related adverse events (AEs) of corneal endothelial cell loss or cystoid macular edema (CME)—and no serious corneal AEs.
Overall: Safety findings were consistent with the well-established safety profile of iDose TR and previous clinical experience.
Any comments from the company?
Per Thomas Burns, Glaukos chairman and CEO: The findings “further reinforce the versatility of iDose TR across various administration settings, demonstrating its ability to deliver clinically meaningful robust IOP reduction whether administered as a standalone procedure or in conjunction with cataract surgery.”
He added: “iDose TR continues to deliver strong clinical outcomes that provide meaningful benefits for patients, helping to accelerate a broader treatment paradigm shift toward earlier, interventional glaucoma care.”
What else should be on my watch list?
Just days earlier, Glaukos reported positive 3-year data from the long-term phase 3 extension study evaluating the durability, visual outcomes, and safety of Epioxa HD / Epioxa (riboflavin 5–phosphate ophthalmic solution 0.239% / 0.177%) for the treatment of keratoconus.
- See here for our full coverage on this.
And prior to that data readout, the company announced in August that it had completed patient enrollment in its U.S. pivotal clinical study supporting the potential 510(k) clearance of the PRESERFLO MicroShunt for adult patients with primary OAG (POAG).
As usual, stay tuned for more updates!