Glaukos Corporation’s iDose TR (travoprost intracameral implant) 75 mcg, designed to address ubiquitous patient non-compliance and chronic side effects associated with topical glaucoma medications, is now commercially available in the United States.
Of note: the micro-invasive glaucoma surgeries (MIGS) device is designed to be used with Celanese Corporation’s ethylene vinyl acetates (EVA), a drug delivery platform (but more on that later).
First, refresh me on this implant.
Approved by the FDA in December 2023 (our coverage here), the iDose TR is a biocompatible titanium implant designed to be administered during micro-invasive glaucoma procedures.
The device consists of a proprietary, preservative-free formulation of (75 mcg) travoprost (see below) that is pre-loaded in a single-dose insert and released inside the anterior chamber.
Explain travoprost.
As a prostaglandin analog used to lower intraocular pressure (IOP), travoprost is indicated for IOP reduction in patients with ocular hypertension (OHT) or open-angle glaucoma (OAG).
See here for the full prescribing info.
How does it work, exactly?
By eluting the drug already inside the eye, the sustained-release MIGS device bypasses the corneal permeability barrier, enabling the release of micro-doses of travoprost over time.
Click here to watch the procedure.
And the effects last how long?
Ideally, the implant is intended to continuously release the medication for at least 1 year.
After the travoprost is finished releasing, the implant can be retrieved and replaced with another implant, if medically necessary.
How has it performed, clinically?
Click here for our coverage on the implant’s exchange trial, which reported the iDose TR demonstrating a favorable safety profile over a 12-month evaluation period.
Prior to that, two pivotal phase 2 trials found the implant to have “a fast- and slow-release capacity against twice-daily (BID) topical timolol ophthalmic solution, 0.5% (the active comparator) over 12 months,” according to Glaukos.
See here for those details.
Any notable adverse events?
Per Glaukos, based on phase 3 trial data, 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).
And any other precautions?
The implant should be used with caution in “patients with narrow angles or other angle abnormalities,” according to its indications and usage. Further, “Increase pigmentation of the iris can occur,” which is likely to be permanent.
Gotcha. Now let’s talk about Celanese’s involvement in this.
In April 2023, Glaukos and Celanese, a Texas-based global speciality materials and chemical company, announced a collaboration in which Glaukos’ iDose TR would combine with Celanese’s VitalDose Ethylene Vinyl Acetate (EVA) copolymer platform to provide an effective sustained-release glaucoma treatment.
Talk about this platform.
The VitalDose EVA copolymer is a biostable technology platform designed to provide controlled and sustained-release performance for drug-eluting implants.
The EVA allows for processing with various manufacturing methods and is compatible with proteins, peptides, and small molecules for specific drug formulations, release, and delivery requirements.
Exactly how do these technologies work together?
With the iDose TR designed to address patient non-adherence and chronic side effects associated with topical medications, the VitalDose EVA is intended to operate as the drug-eluting component of the implant to provide 24/7, around-the-clock (ATC) therapy.
What’s so significant about this duo?
This platform-implant combo’s sustained-release capabilities can potentially provide an alternative, long-lasting, IOP-lowering treatment for glaucoma patients—all without the challenges of adherence and compliance associated with traditional forms of treatment.
“There is now the opportunity to provide continuous dosing which can improve patient compliance and address adherence issues,” stated Glaukos.
Lastly … where can I find this?
While Glaukos has established a wholesale acquisition cost of $13,950 per dose (or implant) for iDose TR, there’s no specific word yet on when training / certification programs might commence for iDose TR—so stay tuned!