New 24-month, topline clinical data from a U.S. pivotal trial demonstrate positive outcomes for the use of Bausch + Lomb Corporation’s ELIOS System for glaucoma management.
Positive data is also a good sign … but let’s start with ELIOS.
B+L acquired the ELIOS System and the same-name procedure in 2024 as part of its acquisition of Elios Vision.
What it is: A microinvasive, implant-free procedure that combines with phacoemulsification and uses excimer laser light energy (see how this benefits the surgeon and patient).
What it does: Creates 10 microscope openings (200 µm) within the trabecular meshwork (TM) to reestablish the flow of aqueous humor into Schlemm’s canal.
- Watch this video for a visual of how the procedure works.
And its purpose?
To treat glaucoma.
More specifically: The procedure is performed during cataract surgery to treat (lower) intraocular pressure (IOP) in patients with open-angle glaucoma (OAG).
Check out the clinical evidence supporting its use for both glaucoma and concomitant glaucoma and cataract patients.
To be clear: This is still investigational, right?
Correct (in the United States, at least). As B+L noted: ELIOS has “not been reviewed by the FDA for safety and efficacy.”
- Outside the U.S., however, the procedure is already CE marked and commercialized in Europe.
So what do we know about the new pivotal study?
- The design: A prospective, interventional multicenter trial (NCT04899063)
- The participants: 318 patients (aged 45+) diagnosed with mild-to-moderate primary OAG (POAG) and:
- Operable cataract, eligible for phaco with a best-corrected visual acuity (BCVA) of 20/40 or worse
- A medicated IOP of <=24 mmHg
- See here for all eligibility criteria
- The setup: Patients undergoing the ELIOS procedure using the ELIOS System.
And the primary objectiveS?
The study had two co-primary effectiveness endpoints, both evaluated at the 24-month mark:
- Patients who achieved at least a 20% reduction in diurnal IOP (DIOP)
- Mean change in medication-free DIOP from baseline
Next up: the data.
For starters: The study met both its objectives, with the ELIOS System demonstrating a “statistically significant and clinically meaningful IOP reduction.”
Just how significant was this reduction?
Over three-fourths (76%) of patients had their unmedicated DIOP reduced by 20% or greater, with an average decrease of 7.4 mmHg.
And how many patients were medication-free by the 24-month mark?
Forget waiting until that time point—B+L reported that 82% of patients were medication-free at 23 months.
Nice! Were there any adverse effects or other complications observed from the procedure?
The company shared that no intraoperative complications were noted during the procedure, while the postoperative adverse event rate was similar to those observed in cataract surgery alone.
- For reference: See here for common cataract surgery-associated AEs (and here for complications), which typically rate below 1%.
Also take note: Detailed results from the trial will be submitted to a future (unnamed) medical meeting and a peer-reviewed journal, according to B+L.
So how do these findings compare to prior data on the system?
Per a B+L webinar on the topline data, these results reinforce “clinically validated 8 years of follow-up data from Europe.”
That data stemmed from a cohort study conducted on patients with glaucoma, ocular hypertension (OHT), or cataract. As reported in 2022, the highlights included:
- A sustained IOP reduction (19.3 mmHg at baseline to 15.4 mmHg; p = 0.0040)
- Significant reduction in medication needs
- Only 3.7% of patients requiring secondary surgical glaucoma intervention
- No serious intra- or postoperative events
And in other European data: The ELIOS System has also undergone evaluation in 12 clinical studies encompassing 850+ treated eyes—and favorable outcomes.
Nice! Now, are there any other clinical trials to be aware of?
In support of B+L’s plan to secure FDA clearance and launch ELIOS in H2 2026, an investigational device exemption (IDE) study (NCT05999006) is underway.
Its purpose: To evaluate the safety and effectiveness of the ELIOS System in reducing IOP among adult patients with mild-to-moderate POAG. See here for more info.
Cleared for initiation in 2023, the study is expected to conclude in April.