Glaukos Corporation has received FDA approval for the iDose TR (travoprost intracameral implant) 75 mcg, designed to address ubiquitous patient non-compliance and chronic side effects associated with topical glaucoma medications.
Refresh me on this implant.
The iDose TR is a biocompatible titanium implant designed to be administered during micro-invasive glaucoma procedures.
The device contains a proprietary, preservative-free formulation of (75 mcg) travoprost—a prostaglandin analog used to lower intraocular pressure (IOP)—pre-loaded in a single-dose insert that is released inside the anterior chamber.
To note, travoprost is indicated for the reduction of IOP in patients with ocular hypertension (OHT) or open-angle glaucoma (OAG).
See here for the full prescribing info.
Go on…
By eluting the drug already inside the eye, the device bypasses the corneal permeability barrier, enabling the release of micro-amounts of travoprost over time.
Click here to watch the procedure.
And how long are these effects supposed to last?
The implant is designed to continuously release the medication for at least 1 year.
Once all the travoprost is released, the implant is removed and could be replaced with another implant.
Gotcha. Refresh me on its clinical data.
Data from two prospective, randomized, multicenter, double-masked, phase 3 pivotal trials (GC-010 and GC-012)—released in September 2022—supported the approval, with each study assessing the performance of the iDose TR as both a fast- and slow-release capacity against twice-daily (BID) topical timolol ophthalmic solution, 0.5% (the active comparator) over 12 months.
Per Glaukos, in both studies, “Both the fast- and slow-release iDose TR arms achieved the pre-specified primary efficacy endpoint of non-inferiority to the active comparator arm… through 3 months.”
And the IOP reduction?
- GC-010 trial: (from baseline to 3 months)
- 6.6 for 8.5 mmHg in slow-release iDose TR arm
- 6.6 to 7.7 mmHg in timolol control arm
- GC-012 trial: (from baseline to 3 months)
- 6.7 to 8.4 mmHg in slow-release iDose TR arm
- 6.8 to 7.2 mmHg in timolol control arm
Did this maintain at 12 months as well?
Per the company, 93% of slow-release iDose TR participants remained well-controlled (vs 67% of timolol control participants) in both studies.
Further, for both studies, 81% of these iDose TR participants were “completely free of IOP-lowering topical medications at 12 months.”
How about the safety profile?
Also at 12 months, “excellent tolerability” was reported in 98% of iDose TR participants (vs 95% for timolol), with a favorable safety profile and no corneal or periorbital fat atrophy adverse events as well as no corneal endothelial cell loss.
This was noted for both trials.
Any other data?
Additional positive data was reported in January 2023 from an exchange trial assessing the safety and feasibility of replacing an iDose TR implant in patients who had received the original implant in a previous phase 2b trial.
Any adverse events to know about?
Per Glaukos, conjunctival hyperemia occurred at a low rate (3%) for slow-release iDose TR, while the most frequent adverse event for this dosage was mild transient iritis (rate of 6% for both trials).
Significance?
The implant’s long-term durability and removability capabilities offers a first-of-its-kind dropless alternative to daily eye drop treatment for OAG and OHT patients.
Lastly … when will it be available?
Glaukos expects to begin the initial commercial launch of the iDose TR in the latter part of Q1 2024.
And as part of this pending launch, the company has created the iDose Your Dose Initiative, where—for every implant sold—Glaukos will pledge to “make available an equal number of iDoseTR units for qualifying charitable donation requests in the U.S. and around the globe for recipients that satisfy independent eligibility requirements.”