Glaukos Corporation announced the release of new data from phase 3 and phase 4 clinical trials as well as the initiation of a phase 2b/3 clinical program for its iDose sustained-release procedural pharmaceutical platform.
First, a refresh on iDose.
The iDose platform encompasses a targeted, minimally-invasive, injectable implant that delivers therapeutic levels of medication from within the eye for extended amounts of time.
Its purpose: To address “ubiquitous patient non-adherence and chronic side effects associated with topical medications by providing 24/7, long-duration, robust efficacy with minimal side effects,” according to Glaukos.
And the iDose products?
There’s currently only one on the market, although a next-generation implant (the iDose TREX) is in development—but more on that later.
The iDose TR (travoprost intracameral implant) 75 mcg is a biocompatible titanium implant designed to be administered during micro-invasive glaucoma procedures (or in combination with cataract surgery).
FDA-approved in December 2023 (with a U.S. commercial launch in March 2024), the device contains a proprietary, preservative-free formulation of travoprost that is pre-loaded in a single-dose insert and released inside the anterior chamber.
- Take note: Travoprost is a prostaglandin analog indicated for intraocular (IOP) reduction in patients with ocular hypertension (OHT) or open-angle glaucoma (OAG).
See here for the full prescribing info.
Is there a visual of how this works?
Now let’s talk about those phase 3 trials.
Initially used to support the new drug application (NDA) submission and later FDA approval of the iDose TR, these pivotal trials were designed as prospective, randomized, double-masked studies (NCT03519386, NCT03868124).
Their purpose: To compare the safety and efficacy of the iDose TR to topical timolol ophthalmic solution, 0.5%, in reducing elevated IOP among patients diagnosed with OAG or OHT.
- The original data: Both pivotal trials not only met their pre-specified primary efficacy endpoints (through 3 months), but also demonstrated the iDose TR’s excellent tolerability and favorable safety profile through 12 months.
And these updated findings?
This new data—stemming from 36-month follow-up analysis of the trials—reported that the iDose TR continued to demonstrate sustained substantial IOP reductions.
- The numbers: An estimated 70% of iDose TR subjects remained well-controlled on the same or fewer IOP-lowering topical medications at 36 months after a single administration of the implant compared to 58% of timolol subjects.
Even further: The iDose TR “continued to demonstrate excellent tolerability and a favorable safety profile through 36 months” in both trials.
That sounds promising … and you mentioned there’s new phase 4 data as well?
Yes! Additional data on the iDose TR includes a 6-month follow-up analysis of a phase 4 single-arm clinical study that evaluated 60 OAG patients who received the implant in combination with cataract surgery.
Those findings: Participants achieved a mean IOP reduction of 11.3 mmHg (44%) at 6 months compared to baseline.
Nice! Now circle back to the phase 2b/3 you mentioned earlier.
Glaukos has initiated a phase 2b/3 clinical program for the iDose TREX, a next-generation version of the iDose platform therapy currently in clinical development and investigation.
What it is: This implant is designed to be similar in both size and form to the original iDose TR—but with nearly twice the drug capacity—potentially reducing the frequency of treatments.
- Its proposed indications: Are in alignment with the iDose platform (glaucoma and OHT).
As for details on this clinical program: Those are still under wraps, but stay tuned for a company update later this year.
Any previous data available on it?
Not the iDose TREX explicitly …
However, findings published last year detailed a phase 3 study evaluated two versions of the implant—a fast-eluting (FE; the iDose TR) and a slow-eluting (SE) implant—when used with twice-daily drops versus a sham procedure with timolol among OAG and OHT patients.
Those findings: Both the FE and SE implants demonstrated a robust IOP reduction over a 3-month period, with the IOP-lowering efficacy in both implant groups noted as statistically and clinically non-inferior to the timolol group.
- See here for more insights on that data.
Interesting … and lastly, what is Glaukos saying about all of this new data?
Chairman and CEO Thomas Burns noted that these clinical updates support the company in advancing its goal to “position iDose as a transformative novel platform technology able to fundamentally improve the treatment paradigm for [OAG and OHT] patients."
He added: “We continue to believe there is an important unmet clinical need and strong appetite within the ophthalmic community for safe, effective and sustained procedural pharmaceutical alternatives to traditional topical medications.”