Latest / Glaucoma, Vision & Longevity: Supplements & Science / Can an Implant-Free Laser Procedure Free Glaucoma Patients From Eye Drops? New 2-Year ELIOS Results
Transcript
- 0:00SPEAKER_00: Can an implant-free laser procedure free glaucoma patients from eye drops?
- 0:04SPEAKER_00: New two-year Ilios results.
- 0:07SPEAKER_00: Bottom line the new 24-month Iliose excimer laser tubeculostomy results are encouraging, but they answer a narrower question than many headlines suggest.
- 0:17SPEAKER_00: The study shows that cataract surgery combined with iliose can produce a sustained reduction in unmedicated eye pressure and allow many patients to stop glaucoma drops for at least two years.
- 0:28SPEAKER_00: In the pivotal study, mean unmedicated diurnal eye pressure fell from approximately 24.5 millimeters of mercury at baseline to 16.8 millimeters of mercury at 24 months, and 82.0% of patients were medication-free around month 23.
- 0:44SPEAKER_00: Galardo et al.
- 0:47SPEAKER_00: However, the central limitation is important.
- 0:50SPEAKER_00: There was no concurrent cataract surgery-only control group.
- 0:54SPEAKER_00: The trial was a prospective, single-arm study that compared its results with historical performance goals derived from earlier minimally invasive glaucoma surgery trials.
- 1:05SPEAKER_00: My interpretation is, Eliose plus cataract surgery works as a combined treatment.
- 1:10SPEAKER_00: It probably provides additional pressure lowering beyond cataract surgery alone.
- 1:15SPEAKER_00: The most reasonable estimate of the additional ileose effect at 24 months is approximately 1.5 to 2.5 millimeters of mercury, with a plausible range of roughly 1 to 3 mm of mercury.
- 1:29SPEAKER_00: The medication-free benefit may be real and clinically valuable, but the exact size of that benefit is less certain without a randomized control arm.
- 1:38SPEAKER_00: Iliose appears best suited to patients with mild to moderate primary open-angle glaucoma who already need cataract surgery.
- 1:46SPEAKER_00: It should not be viewed as a replacement for trabeculectomy or tube surgery in patients needing an eye pressure below 12 mm of mercury or in many patients with advanced glaucoma.
- 1:57SPEAKER_00: The original paper was published online on September 8, 2026, and the two-year results were presented at the European Society of Cataract and Refractive Surgeons Congress in London from September 10th through September 14th, 2026.
- 2:14SPEAKER_00: What is Elios?
- 2:15SPEAKER_00: Elios is an implant-free form of Exzymer laser tubeculostomy.
- 2:20SPEAKER_00: Instead of leaving a stent inside the eye, the procedure uses a 308-nometer xenon chloride Exzymer laser to create small openings through the trabecular meshwork, the eye's main drainage tissue.
- 2:33SPEAKER_00: These openings are intended to provide a more direct route for fluid to enter Schlem's canal and then reach the eye's natural collector channels.
- 2:41SPEAKER_00: The current Elios treatment creates 10 microchannels, each approximately 210 micrometers in diameter, across approximately 90 to 110 degrees of the nasal trabecular meshwork, after cataract removal and placement of an intraocular lens.
- 2:59SPEAKER_00: The procedure is performed through a small corneal incision under gonioscopic visualization.
- 3:05SPEAKER_00: It is described as non-thermal photoablation, meaning that tissue is removed by breaking molecular bonds rather than by burning or coagulating tissue.
- 3:13SPEAKER_00: The 2026 Pivotal Study, Exact Design, Study Design.
- 3:19SPEAKER_00: The pivotal trial was prospective multi-center non-randomized single arm conducted under a United States investigational device exemption, registered as NCTO48963, conducted at 20 United States sites.
- 3:32SPEAKER_00: Treatment period, approximately June 2021 through July 2023.
- 3:37SPEAKER_00: Published as a 24-month report in ophthalmology glaucoma.
- 3:41SPEAKER_00: The study included 318 patients who underwent cataract surgery followed by Elios.
- 3:47SPEAKER_00: Clinical Trials.gov study record.
- 3:49SPEAKER_00: How many patients completed 24 months?
- 3:52SPEAKER_00: This point requires careful wording.
- 3:54SPEAKER_00: The original paper's abstract reports 318 treated patients and presents the 24-month efficacy percentages using figures that correspond closely to a 318 patient denominator.
- 4:05SPEAKER_00: 84.2% at 12 months corresponds to approximately 268 of 318.
- 4:12SPEAKER_00: 76.1% at 24 months corresponds to approximately 242 of 318.82.
- 4:18SPEAKER_00: 0% medication-free around month 23 corresponds to approximately 261 of 318.
- 4:26SPEAKER_00: A conference report described the study as involving 318 patients who completed the two-year cohort, but the PubMed abstract does not provide a separate conventional patient flow table showing enrollment, losses to follow-up, exclusions, and the exact number available at every visit.
- 4:42SPEAKER_00: Therefore, the most defensible statement is 318 patients underwent the combined procedure, and the published endpoint percentages appear to use the 318 patient analysis population.
- 4:56SPEAKER_00: The publicly visible abstract does not separately document a detailed 24-month completer denominator.
- 5:02SPEAKER_00: That distinction matters because a study can report an analysis percentage based on available or imputed data without every patient completing every examination.
- 5:12SPEAKER_00: Who was included?
- 5:13SPEAKER_00: The study enrolled adults who had age of at least 45 years, mild to moderate primary open-angle glaucoma, an operable age-related cataract.
- 5:23SPEAKER_00: Best corrected visual acuity of approximately 2040 or worse, according to the trial eligibility description.
- 5:30SPEAKER_00: Medicated eye pressure of 24 mm of mercury or less.
- 5:34SPEAKER_00: Treatment with 1 to 3 glaucoma medications, unmedicated mean diurnal eye pressure between 22 and 34 mm of mercury after medication washout.
- 5:44SPEAKER_00: The study therefore did not primarily test ELIOS in patients with advanced disease, very low target pressures, or highly medication-resistant glaucoma.
- 5:54SPEAKER_00: Baseline medication use.
- 5:57SPEAKER_00: The mean baseline medication burden reported in the 12-month conference abstract was approximately 1.5 medications.
- 6:04SPEAKER_00: Standard deviation, approximately 0.7 medications.
- 6:08SPEAKER_00: This is important.
- 6:09SPEAKER_00: The study population was not made up mainly of patients taking four or five medications.
- 6:14SPEAKER_00: It was largely a mild to moderate glaucoma population with a modest medication burden.
- 6:19SPEAKER_00: Baseline eye pressure.
- 6:21SPEAKER_00: The study reported mean medicated eye pressure at screening 17.05 plus 3.01 mm of mercury.
- 6:30SPEAKER_00: Mean unmedicated diurnal eye pressure at baseline, 24.53 plus 2.51 mm of mercury.
- 6:38SPEAKER_00: The unmedicated diurnal measurement was taken after glaucoma medications had been stopped according to the study protocol, washout protocol.
- 6:45SPEAKER_00: The public abstract confirms that patients had to reach the required unmedicated diurnal eye pressure range after washout.
- 6:52SPEAKER_00: However, the abstract does not list the exact medication-specific washout durations.
- 6:57SPEAKER_00: For example, the number of days required for prostaglandin analogs, beta blockers, or carbonic anhydrase inhibitors.
- 7:06SPEAKER_00: That information should not be inferred from another trial.
- 7:09SPEAKER_00: Hydris and eye stent pivotal trials also used medication washouts, but their exact schedules and visit procedures were not necessarily identical to those used in Eelios.
- 7:19SPEAKER_00: The Eelios publication therefore supports the statement that the baseline pressure was measured after medication washout, but the publicly available abstract does not allow a complete reconstruction of the washout timetable.
- 7:32SPEAKER_00: Cataract surgery procedure.
- 7:34SPEAKER_00: Patients underwent standard phacoemulsification cataract extraction, placement of an intraocular lens, ileose excimer laser tubeculostomy after the cataract portion was completed.
- 7:47SPEAKER_00: The trial therefore studied a combined operation, not eliose in isolation, the pre-specified primary endpoints.
- 7:53SPEAKER_00: The study had two co-primary efficacy endpoints at both 12 and 24 months.
- 7:58SPEAKER_00: Endpoint one, percentage achieving at least a 20% pressure reduction.
- 8:03SPEAKER_00: The percentage of patients had to achieve at least a 20% reduction in unmedicated mean diurnal eye pressure from baseline.
- 8:10SPEAKER_00: The prespecified performance goals were 12 months, greater than 79%, 24 months, greater than 68.5%, N.2 mean change in unmedicated diurnal eye pressure.
- 8:23SPEAKER_00: The mean reduction in unmedicated diurnal eye pressure had to meet 12 months, at least 7.2 mm of mercury, 24 months, at least 6.15 millimeters of mercury.
- 8:35SPEAKER_00: These were not comparisons against a contemporaneous cataract-only group.
- 8:39SPEAKER_00: They were comparisons against historical performance goals derived from cataract-only arms in prior, minimally invasive glaucoma surgery trials.
- 8:48SPEAKER_00: Exact 24-month results.
- 8:50SPEAKER_00: The results reported in the original paper were, for the full table, please open this article on VisualFieldTest.com.
- 8:57SPEAKER_00: The 12-month result represented approximately a 34.5% reduction, while the 24-month change represented approximately a 30% reduction from the washed-out baseline pressure, depending on whether one uses the reported group means or the paired endpoint estimates.
- 9:15SPEAKER_00: A small arithmetic issue is worth noting.
- 9:18SPEAKER_00: The reported mean pressure at each visit does not subtract exactly from the reported mean change because endpoint analyses may use different available patient populations or model-based estimates.
- 9:31SPEAKER_00: The two numbers should therefore not be forced into a simple subtraction equation.
- 9:36SPEAKER_00: The most important correction to circulating coverage is this.
- 9:39SPEAKER_00: 24.53 mm of mercury was the baseline unmedicated pressure, not the 24-month pressure.
- 9:46SPEAKER_00: The reported 24-month mean pressure was 16.76 mm of mercury.
- 9:52SPEAKER_00: The original paper is the appropriate source for these values.
- 9:56SPEAKER_00: How durable was the medication-free result?
- 9:59SPEAKER_00: At approximately month 23, 82.0% of patients were reported to be medication free.
- 10:06SPEAKER_00: That is a strong result, but it should be interpreted carefully.
- 10:10SPEAKER_00: Medication-free does not mean that the glaucoma was cured.
- 10:13SPEAKER_00: It means that at that point in follow-up, the patient was not using pressure-lowering glaucoma medication under the study's treatment algorithm.
- 10:22SPEAKER_00: The result may be clinically meaningful because avoiding drops can reduce daily treatment burden, preservative exposure, ocular surface irritation, cost problems with adherence, but medication-free rates can be influenced by how aggressively investigators stopped medications, whether medications were restarted for relatively small pressure increases, baseline disease severity, the number of medications patients were taking before surgery, the absence of a randomized control group, safety findings.
- 10:53SPEAKER_00: The pivotal publication described the safety profile as favorable and broadly consistent with cataract surgery alone.
- 11:00SPEAKER_00: Reported findings included no interoperative adverse events during the ileose portion of surgery, five adverse events during cataract extraction and intraocular lens implantation.
- 11:11SPEAKER_00: At 12 months, 144 ocular adverse events in 107 patients, or approximately 33.6 cent, approximately 68 cent of these events occurred during the first postoperative month.
- 11:24SPEAKER_00: Most were mild to moderate and did not produce clinically significant lasting effects.
- 11:28SPEAKER_00: Sustained or later onset tie pressure elevation was reported in approximately 1.5 cent.
- 11:34SPEAKER_00: Best corrected visual acuity of at least 2040 was achieved in all patients at 12 months in the conference safety analysis.
- 11:41SPEAKER_00: Endothelial cell loss occurred early and then stabilized by approximately month 3 through month 24.
- 11:46SPEAKER_00: The Abstract does not provide a detailed numerical percentage for end-of-the-lial cell loss, nor does it provide a clearly stated 24-month reoperation rate that limits direct safety comparison with devices for which those data have been more fully published.
- 12:02SPEAKER_00: The biggest methodological problem: no concurrent cataract-only control group.
- 12:07SPEAKER_00: The study's main weakness is not that it was prospective or multi-center.
- 12:12SPEAKER_00: Those are strengths.
- 12:13SPEAKER_00: The major weakness is that every patient received both cataract surgery and ileos.
- 12:18SPEAKER_00: There was no group receiving the same cataract surgery at the same time in the same participating centers with the same medication management protocol without Eelios.
- 12:29SPEAKER_00: Instead, the results were compared against pre-specified performance goals based on previous cataract-only control groups.
- 12:36SPEAKER_00: Why this matters?
- 12:37SPEAKER_00: Cataract surgery alone can lower eye pressure, particularly in patients with higher baseline pressure.
- 12:43SPEAKER_00: The pressure reduction may persist for years, although the initial effect often weakens after the first two years.
- 12:51SPEAKER_00: A systematic review found that cataract surgery alone can produce a lasting pressure reduction, with gradual loss of the initial effect over time.
- 12:59SPEAKER_00: FACO emulsification meta-analysis.
- 13:03SPEAKER_00: A historical control is not the same as a randomized control because the studies may differ in patient selection, glaucoma severity, ethnic composition cataract severity, baseline pressure, medication burden, pressure measurement schedule, washout procedures, surgeon experience, postoperative medication tapering, criteria for restarting glaucoma drops.
- 13:25SPEAKER_00: The LES performance goals were pre-specified, which is better than choosing a comparison after seeing the results.
- 13:31SPEAKER_00: But passing a pre-specified performance goal does not prove that Elios is superior to cataract surgery alone in the same patient population.
- 13:39SPEAKER_00: How much pressure reduction might cataract surgery alone have produced?
- 13:43SPEAKER_00: The most useful evidence comes from randomized cataract-only control groups in the hydrus and eye stent pivotal trials, hydrous cataract-only controls.
- 13:53SPEAKER_00: In the Horizon trial, patients were randomized to cataract surgery with hydrous or cataract surgery alone.
- 14:00SPEAKER_00: At 24 months, hydris plus cataract surgery mean unmedicated pressure reduction, approximately 7.6 mm of mercury.
- 14:08SPEAKER_00: Cataract surgery alone, approximately 5.3 mm of mercury.
- 14:12SPEAKER_00: Mean 24 month unmedicated pressure, approximately 16.9 versus 19.2 mm of mercury.
- 14:19SPEAKER_00: At least 20% reduction, approximately 77.3% versus 57.8%.
- 14:26SPEAKER_00: E-stent inject cataract-only controls.
- 14:28SPEAKER_00: In the pivotal ISTEN inject trial at 24 months, I stent inject plus cataract surgery, mean unmedicated pressure reduction, approximately 7.0 mm of mercury.
- 14:39SPEAKER_00: Cataract surgery alone, approximately 5.4 millimeters of mercury.
- 14:43SPEAKER_00: Mean unmedicated pressure, approximately 17.1 versus 17.8 millimeters of mercury.
- 14:50SPEAKER_00: At least 20% reduction, approximately 75.8% versus 61.9%, medication free at approximately month 23, 74.5% versus 54.1%, two-year eye-Stenjeck Pivotal Analysis and United States Food and Drug Administration summary.
- 15:07SPEAKER_00: A reasonable estimate for Elios, the Elios baseline unmedicated pressure was 24.53 millimeters of mercury, very similar to the historical hydrous and eye stent control populations.
- 15:18SPEAKER_00: Elios produced a mean reduction of 7.35 millimeters of mercury at 24 months.
- 15:24SPEAKER_00: If cataract surgery alone would have produced approximately 5.3 to 5.4 millimeters of mercury of reduction in a similar population, the estimated additional Elios effect would be 7.35 minus 5.3 equals approximately 2.05 millimeters of mercury.
- 15:41SPEAKER_00: 7.35 minus 5.4 equals approximately 1.95 millimeters of mercury.
- 15:48SPEAKER_00: Because historical comparisons are imperfect, my best estimate is true additional Eliose pressure reduction beyond cataract surgery alone at 24 months, approximately 2 mm of mercury, with a plausible range of 1 to 3 mm of mercury.
- 16:03SPEAKER_00: That is not trivial.
- 16:04SPEAKER_00: A 2 millimeter reduction can be clinically useful for a patient whose pressure is hovering around 18 or 19 millimeters of mercury and who wants to avoid another medication, but it is not a dramatic pressure-lowering effect comparable to trabeculectomy.
- 16:20SPEAKER_00: Quantitative comparison with other procedures.
- 16:23SPEAKER_00: The following table is intentionally cautious.
- 16:26SPEAKER_00: Many glaucoma studies do not use medication washout, do not measure diurnal pressure, or define success differently.
- 16:34SPEAKER_00: The numbers should therefore not be read as a league table.
- 16:37SPEAKER_00: For the full table, please open this article on VisualFieldTest.com.
- 16:42SPEAKER_00: Sources for the comparator data include the Horizon trial, the I-Stent Inject Pivotal Trial, the Cahook Dual Blade 24-month series, the Romeo Omni study, published gonioscopy-assisted transluminal tubeculotomy cohorts, and the earlier Exzymer laser versus selective laser trabeculoplasty randomized study.
- 17:01SPEAKER_00: Why these comparisons are imperfect.
- 17:04SPEAKER_00: The Elios Pivotal Study is unusual because it used medication washout, mean diurnal pressure, a baseline pressure of approximately 24, 5 mm of mercury, a percentage reduction endpoint, a mild to moderate cataract and glaucoma population, many kahok dual-blade, omni, and gonioscopy-assisted transluminal trabeculotomy studies instead report medicated pressure, a single office pressure measurement, more severe disease.
- 17:32SPEAKER_00: Retrospective outcomes.
- 17:34SPEAKER_00: Different medication reduction definitions.
- 17:36SPEAKER_00: An apparently lower postoperative pressure in one study does not necessarily mean the procedure was more powerful.
- 17:43SPEAKER_00: Why might Eximer laser behave differently from mechanical trabeculotomy?
- 17:47SPEAKER_00: Photoablation rather than thermal injury.
- 17:50SPEAKER_00: The Elios Eximer laser removes tissue through photoablation.
- 17:54SPEAKER_00: It is designed to create a precise opening while producing little thermal spread.
- 17:58SPEAKER_00: This differs from selective laser trabeculoplasty, which uses laser energy to stimulate biological changes in trabecular cells.
- 18:06SPEAKER_00: Kahook dual blade, which physically excises a strip of trabecular meshwork, gonioscopy-assisted transluminal trabeculotomy, which tears or incises the trabecular meshwork over a large arc, Omni, which combines canal dilation with trabeculotomy, hydris and eye stent, which leave a device inside the outflow pathway.
- 18:27SPEAKER_00: The theoretical advantage of photoablation is less collateral damage to the surrounding tissue and potentially less scarring.
- 18:35SPEAKER_00: The limitation is that this biological advantage has not yet been proven in a large head-to-head randomized trial.
- 18:42SPEAKER_00: Less tissue disruption may mean less inflammation.
- 18:45SPEAKER_00: Mechanical angle surgery can produce blood reflux from Schlem's canal.
- 18:49SPEAKER_00: This is expected in many trabeculotomy procedures, but it can cause temporary hyphema, blurred vision, short-term pressure elevation, more postoperative inflammation.
- 19:01SPEAKER_00: Elios also creates communication with Schlem's canal, so blood reflux can occur.
- 19:05SPEAKER_00: However, it creates only 10 small openings rather than removing or cutting a large continuous segment of trabecular meshwork.
- 19:12SPEAKER_00: The resulting balance is uncertain.
- 19:14SPEAKER_00: Potential advantage, less tissue disruption and less foreign material.
- 19:19SPEAKER_00: Potential disadvantage, fewer openings, and a smaller treated angle may limit total outflow.
- 19:25SPEAKER_00: Access to Schlem's canal is not the entire story.
- 19:28SPEAKER_00: Opening the trabecular meshwork is only the first step.
- 19:31SPEAKER_00: Fluid must still pass through Schlem's canal.
- 19:34SPEAKER_00: Collector channel openings, intrascleral vessels, episcleral veins.
- 19:39SPEAKER_00: A recent aqueous outflow angiography study found improved outflow after Ilios, including some improvement beyond the immediate treatment area.
- 19:47SPEAKER_00: However, the study involved only six eyes from five patients and emphasized that uneven Schlem's canal anatomy and limited collector channel access may restrict the achievable pressure reduction.
- 19:58SPEAKER_00: Aqueous outflow study.
- 20:01SPEAKER_00: Could the openings close?
- 20:03SPEAKER_00: Closure is biologically possible.
- 20:05SPEAKER_00: The openings could become less effective because of fibrin or blood, fibroblast activity, scar tissue, progressive dysfunction of Schlem's canal, distal collector channel disease.
- 20:17SPEAKER_00: The Elios mechanism is intended to reduce this risk because it is non-thermal and precise.
- 20:23SPEAKER_00: But the pivotal study did not provide serial, large-scale direct imaging, proving that all 10 openings remained open in every patient.
- 20:31SPEAKER_00: Older clinical studies have shown that Exzymer laser trabeculostomy effects can persist for years.
- 20:37SPEAKER_00: One eight-year retrospective study included both standalone Exzimer laser treatment and combined treatment with cataract surgery.
- 20:45SPEAKER_00: In the combined group, mean pressure fell from approximately 21.9 to 13.7 millimeters of mercury at eight years, but only 13 eyes remained available at the eight-year time point.
- 20:58SPEAKER_00: The standalone group also showed pressure reduction, but only 19 eyes remained at 8 years.
- 21:04SPEAKER_00: This is evidence of possible durability, not proof that the original microchannels remained continuously patent in all treated eyes.
- 21:12SPEAKER_00: Will the effect last two, five, or 10 years?
- 21:16SPEAKER_00: Two years.
- 21:16SPEAKER_00: Reasonably supported.
- 21:18SPEAKER_00: The 2026 pivotal study provides the strongest current evidence for Elios plus cataract surgery through two years.
- 21:25SPEAKER_00: The pressure reduction declined modestly from approximately 8.17 millimeters of mercury at 12 months to 7.35 millimeters at 24 months.
- 21:36SPEAKER_00: That pattern suggests some loss of effect, but not a rapid collapse.
- 21:40SPEAKER_00: Five years plausible, but not established by the pivotal trial.
- 21:44SPEAKER_00: A 2026 conference report described a retrospective five year real world series of 129 eyes treated with combined cataract surgery and ELEOS.
- 21:54SPEAKER_00: At five years, mean medicated pressure was approximately 17.5 millimeters of mercury.
- 22:00SPEAKER_00: Mean medication use fell from 1.74 to 0.50 medications.
- 22:05SPEAKER_00: Approximately 62% of patients required no medications.
- 22:08SPEAKER_00: Approximately 7% required additional surgery.
- 22:11SPEAKER_00: However, that study was retrospective single center, not randomized, a mixture of open-angle glaucoma and ocular hypertension, based on medicated rather than washed-out pressure, subject to loss to follow-up and treatment selection bias.
- 22:26SPEAKER_00: A separate five-year analysis of 73 eyes examined visual field and retinal nerve fiber layer progression.
- 22:33SPEAKER_00: It suggested stability close to expected age-related change, but it did not prove that Elios prevented glaucoma progression compared with a control group.
- 22:43SPEAKER_00: 10 years, not established.
- 22:45SPEAKER_00: There are older eight-year Eximer laser trabeculostomy reports, but they are not equivalent to the new United States ELEOS pivotal trial.
- 22:52SPEAKER_00: Their limitations include retrospective design, heterogeneous glaucoma types, older laser systems or procedural variations, large losses to follow-up, small numbers remaining at the final time point, no randomized cataract-only comparison.
- 23:08SPEAKER_00: Therefore, two-year durability, supported, five-year durability, plausible, but lower certainty.
- 23:14SPEAKER_00: Ten-year durability, unknown.
- 23:16SPEAKER_00: Could Elios eventually be used without cataract surgery?
- 23:19SPEAKER_00: Technically, yes.
- 23:20SPEAKER_00: Eximer laser tubeculostomy was developed as a standalone angle procedure and has been used in Europe for many years.
- 23:27SPEAKER_00: The procedure has had a European regulatory history, including a reported CE mark since 2014.
- 23:34SPEAKER_00: An earlier eight-year retrospective study evaluated 90 eyes treated with excimer laser tubeculostomy alone, 74 eyes treated with excimer laser tubeculeculostomy plus cataract surgery.
- 23:46SPEAKER_00: In the standalone group, baseline pressure, approximately 22.2 mm of mercury, one-year pressure, approximately 16.8 mm of mercury, eight-year pressure, approximately 15.9 mm of mercury, based on only 19 eyes, medications, approximately 1.85 at baseline, 1.19 at one year, and 1.4 at 8 years.
- 24:10SPEAKER_00: This suggests that standalone treatment can work, but the long-term evidence is not robust enough to define its true average effect.
- 24:18SPEAKER_00: A separate United States standalone Elios clinical study was registered as a prospective, multi-center safety and feasibility trial.
- 24:26SPEAKER_00: Public trial tracking information indicates a planned or listed completion date in 2026, but no mature results were publicly available in the material reviewed for this article as of September 22nd, 2026.
- 24:40SPEAKER_00: Standalone Elios trial record.
- 24:42SPEAKER_00: Would standalone Elios compete with selective laser trabeculoplasty?
- 24:47SPEAKER_00: Possibly, but it would have to overcome several disadvantages.
- 24:50SPEAKER_00: Selective laser trabeculoplasty is performed in the office, incision-free, usually less expensive, repeatable, supported by a large body of randomized evidence.
- 25:01SPEAKER_00: Elios would offer direct physical bypass of the trabecular meshwork, no implanted device, potentially more predictable access to Schlem's canal.
- 25:10SPEAKER_00: The possibility of a longer-lasting structural opening.
- 25:13SPEAKER_00: A small randomized study of earlier Exzymer laser trabeculostomy compared with 180 degrees selective laser trabeculoplasty found at two years.
- 25:22SPEAKER_00: Exzymer laser trabeculostomy, approximately 25.0 to 17.6 mm of mercury.
- 25:29SPEAKER_00: Selective laser trabeculoplasty, approximately 23.9 to 19.1 mm of mercury.
- 25:36SPEAKER_00: But the trial included only 15 eyes per group, and it was not the modern Elios pivotal study.
- 25:42SPEAKER_00: It is therefore suggestive rather than definitive.
- 25:45SPEAKER_00: To become a strong competitor to selective laser trabeculoplasty as a standalone treatment, Elios would need a randomized study showing a meaningful advantage in long-term pressure control, medication-free survival, repeat treatment rates, quality of life, cost effectiveness, need for later surgery.
- 26:04SPEAKER_00: Which patients are most likely to benefit?
- 26:06SPEAKER_00: Mild glaucoma.
- 26:08SPEAKER_00: This is probably the most favorable group.
- 26:10SPEAKER_00: A patient with mild glaucoma, a visually significant cataract, and one or two pressure-lowering medications may value a modest additional pressure reduction, freedom from eye drops, a low risk of serious complications, preservation of future treatment options.
- 26:27SPEAKER_00: For these patients, a 2mm pressure advantage can be meaningful if it changes the patient from needing a medication to not needing one.
- 26:35SPEAKER_00: Moderate glaucoma.
- 26:37SPEAKER_00: The pivotal study included moderate disease, so Elios may be reasonable for selected patients with moderate glaucoma undergoing cataract surgery.
- 26:46SPEAKER_00: However, the decision depends on the target pressure.
- 26:49SPEAKER_00: A patient whose target is approximately 15 to 17 millimeters of mercury may be a reasonable candidate.
- 26:56SPEAKER_00: A patient who needs a target near 10 to 12 millimeters of mercury is a different situation.
- 27:03SPEAKER_00: Advanced glaucoma.
- 27:04SPEAKER_00: The pivotal study was not designed to establish efficacy in advanced glaucoma.
- 27:09SPEAKER_00: Advanced glaucoma patients often need lower target pressures, more predictable pressure control, less tolerance for postoperative pressure fluctuations, a treatment capable of bypassing more of the diseased outflow system.
- 27:23SPEAKER_00: Elios may sometimes be used as part of an individualized treatment plan, but current evidence does not support presenting it as a reliable primary operation for advanced disease.
- 27:34SPEAKER_00: Patients already taking several medications more.
- 27:37SPEAKER_00: The pivotal study permitted one to three medications, but the mean baseline burden was only approximately 1.5 medications.
- 27:46SPEAKER_00: A patient taking four or more medications may have more advanced or more resistant outflow disease.
- 27:51SPEAKER_00: In that setting, the average incremental effect of Elios may be smaller and the probability of needing additional surgery may be greater.
- 27:59SPEAKER_00: The CAHOOK dual blade, omni, and gonioscopy-assisted transluminal tubeculatic.
- 28:05SPEAKER_00: The American Society of Retina Specialists' 2026 comments also stated that no United States Food and Drug Administration approved or cleared device for AB internal laser tubeculostomy was available at the time of that document.
- 28:20SPEAKER_00: Regulatory status can change quickly, so patients and surgeons should verify the current Food and Drug Administration database and product labeling before assuming United States availability.
- 28:31SPEAKER_00: Established evidence, reasonable inference, and speculation.
- 28:36SPEAKER_00: Established trial data.
- 28:37SPEAKER_00: The 2026 pivotal study established that Elios plus cataract surgery reduced unmedicated diurnal eye pressure through 24 months.
- 28:46SPEAKER_00: Mean pressure was approximately 15.98 at 12 months and 16.76 at 24 months.
- 28:53SPEAKER_00: Mean pressure reduction was approximately 8.17 and 7.35 millimeters of mercury.
- 28:59SPEAKER_00: At least 20% pressure reduction occurred in 84.2% at 12 months and 76.1% at 24 months.
- 29:07SPEAKER_00: Approximately 82.0% were medication-free around month 23.
- 29:12SPEAKER_00: No intraoperative adverse events occurred during the Elios portion of surgery.
- 29:16SPEAKER_00: Endothelial cell loss stabilized after the early postoperative period.
- 29:21SPEAKER_00: Reasonable inference, it is reasonable to infer that Elios probably contributed additional pressure, lowering beyond cataract surgery alone.
- 29:30SPEAKER_00: The additional average pressure reduction is probably around 2 mm of mercury at 24 months.
- 29:36SPEAKER_00: Elios may provide a medication-free advantage over cataract surgery alone.
- 29:41SPEAKER_00: The lack of a retained implant may reduce some device-specific complications.
- 29:46SPEAKER_00: The non-thermal mechanism may reduce some forms of collateral tissue injury and scarring.
- 29:51SPEAKER_00: Speculation, it remains speculative that Elios is superior to hydris, eye stent inject, omni, cahook dual blade, or gonioscopy-assisted transluminal tubeculotomy.
- 30:02SPEAKER_00: All ten openings remain patent for five or ten years.
- 30:05SPEAKER_00: Elios slows glaucoma progression better than cataract surgery alone.
- 30:09SPEAKER_00: Elios meaningfully reduces the eventual need for trabeculectomy or tube surgery.
- 30:14SPEAKER_00: Elios will become widely used in patients without cataracts.
- 30:18SPEAKER_00: Elios will replace selective laser trabeculoplasty.
- 30:21SPEAKER_00: My quantitative estimates, these are estimates, not trial results.
- 30:26SPEAKER_00: Estimated additional pressure reduction from Ilius.
- 30:29SPEAKER_00: Best estimate at 24 months, approximately 2.0 millimeters of mercury beyond cataract surgery alone.
- 30:36SPEAKER_00: Plausible range, approximately 1 to 3 mm of mercury.
- 30:40SPEAKER_00: Confidence, moderate low, because the estimate depends on historical rather than randomized concurrent controls.
- 30:47SPEAKER_00: Probability that medication-free benefit persists to 5 years.
- 30:51SPEAKER_00: For appropriately selected mild to moderate patients undergoing cataract surgery.
- 30:56SPEAKER_00: Probability that a meaningful medication-free advantage remains at 5 years, approximately 55%.
- 31:02SPEAKER_00: Probability that the very high 82% medication-free rate remains unchanged, approximately 25% to 35%.
- 31:10SPEAKER_00: Likely 5-year medication-free proportion in routine practice, approximately 50 to 65%.
- 31:16SPEAKER_00: This estimate is informed by the 24-month pivotal result, older 8-year data, and the five-year retrospective reports, but it is not directly measured in the pivotal trial.
- 31:27SPEAKER_00: Probability that Ilios becomes widely used.
- 31:30SPEAKER_00: My estimate, approximately 35 to 45%, chance of broad adoption over the next five years.
- 31:36SPEAKER_00: If United States regulatory clearance and reimbursement are obtained, higher adoption probability in cataract-focused practices, lower adoption probability among glaucoma specialists, if the incremental pressure benefit remains only around 2 mm of mercury and no randomized control trial is produced, adoption will depend less on whether Elios works at all and more on whether it provides a clearly superior balance of medication reduction, durability, surgical simplicity, cost reimbursement, repeatability, safety, probability that Elios meaningfully reduces later filtration surgery.
- 32:10SPEAKER_00: My estimate, approximately 25% to 35% probability that future comparative evidence will show a meaningful reduction in later trabeculectomy or tube surgery.
- 32:20SPEAKER_00: Currently, the pivotal trial does not prove this outcome.
- 32:24SPEAKER_00: The older eight-year ELEOS literature is too heterogeneous and incomplete to establish it.
- 32:29SPEAKER_00: A successful pressure reduction in mild to moderate glaucoma may delay escalation, but that is not the same as proving a reduction in filtration surgery.
- 32:39SPEAKER_00: How much of the result is elio, and how much is cataract surgery?
- 32:43SPEAKER_00: The combined elliose result is undeniably strong.
- 32:46SPEAKER_00: Baseline unmedicated pressure, approximately 24.5 pressure at 24 months, approximately 16.8.
- 32:54SPEAKER_00: Mean reduction, approximately 7.35.
- 32:57SPEAKER_00: Medication free rate, approximately 82%.
- 33:00SPEAKER_00: But cataract surgery alone is not an inactive placebo.
- 33:04SPEAKER_00: In comparable randomized studies, cataract surgery alone produced approximately 5.3 to 5.4 millimeters of mercury of unmedicated pressure reduction at two years.
- 33:14SPEAKER_00: That leads to the most reasonable quantitative interpretation.
- 33:17SPEAKER_00: For the full table, please open this article on VisualFieldTest.com.
- 33:22SPEAKER_00: So my answer is roughly 70 to 75% of the average pressure reduction may be attributable to cataract surgery and the underlying postoperative course, while approximately 25 cent to 30% may represent the additional Iliose effect.
- 33:38SPEAKER_00: That percentage is an approximation, not a direct measurement.
- 33:41SPEAKER_00: It is based on historical cataract-only control data, not a randomized Eelios versus cataract surgery trial.
- 33:49SPEAKER_00: The clinical importance of Elios may nevertheless be greater than its average pressure contribution suggests.
- 33:56SPEAKER_00: A 2mm pressure advantage can be enough to eliminate one medication for a patient who otherwise would remain on drops.
- 34:03SPEAKER_00: For a patient with mild to moderate glaucoma, a target pressure in the mid-teens, and a visually significant cataract, that may be a worthwhile benefit.
- 34:12SPEAKER_00: For patients with advanced glaucoma, multiple medications, or a target pressure below 12 mm of mercury, the same evidence is much less persuasive.
- 34:22SPEAKER_00: In those situations, Elio should be viewed as a potentially useful pressure-lowering adjunct, not as a substitute for treatments capable of achieving very low pressures.
- 34:33SPEAKER_00: All links to sources are available in the text version of this article.
- 34:37SPEAKER_00: You can find the full article at Visualfieldtest.com.
- 34:41SPEAKER_00: Thanks for listening.
- 34:42SPEAKER_00: To check your visual field, click the link at the bottom of this article or visit VisualFieldtest.com.