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Bausch + Lomb releases Elios results

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Executive Summary
- Bausch + Lomb announced positive 24‑month results from the pivotal U.S. trial of its Elios™ laser system for treating open‑angle glaucoma.
- The study met both co‑primary endpoints: 76% of patients achieved ≥20% IOP reduction and average unmedicated diurnal IOP fell by 7.4 mmHg.
- 82% of participants were medication‑free at 23 months, with no intra‑operative complications reported.
Key Details
- Study Design: Prospective, multicenter trial across 20 U.S. sites; 318 patients on glaucoma meds enrolled; patients had mild‑moderate primary open‑angle glaucoma and cataracts.
- Co‑Primary Endpoints:
- ≥20% reduction in unmedicated diurnal IOP (DIOP) – achieved by 76% of patients.
- Mean IOP reduction – average decrease of 7.4 mmHg in unmedicated DIOP.
- Medication Freedom: 82% of patients were off glaucoma medication at the 23‑month follow‑up.
- Safety Profile: No intra‑operative complications; postoperative adverse events comparable to cataract surgery alone.
- Regulatory Status: Elios™ is CE‑marked in Europe and under U.S. development; not yet FDA‑reviewed for safety or efficacy.
- Future Disclosure: Full data will be presented at the Bausch + Lomb R&D teach‑in webinar (1:30 p.m. ET) and submitted to a future medical meeting and peer‑reviewed journal.
Notable Quotes
“These strong U.S. study results reinforce everything we've learned about Elios during the years it has been available in Europe… Achieving meaningful reductions in intraocular pressure and freedom from medication for a majority of patients speaks to the promise of this technology.” – Dr. Yehia Hashad, EVP R&D & CMO, Bausch + Lomb
“The Elios procedure shows exciting potential for minimally invasive glaucoma treatment in the U.S., leveraging precision excimer laser technology to enhance the eye's natural outflow pathways.” – Dr. Mark J. Gallardo, Glaucoma Fellowship Director, El Paso Eye Surgeons
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