Bausch + Lomb reports positive 24-month US trial results for ELIOS glaucoma system

Bausch + Lomb has announced positive 24-month results from a pivotal US clinical trial of the ELIOS System, an implant-free procedure that uses excimer laser technology to treat elevated intraocular pressure (IOP) in patients with open-angle glaucoma. The system is CE marked in Europe and remains under development in the US, where it has not been reviewed by the FDA for safety and efficacy, according to a news release.

“These strong US study results reinforce everything we’ve learned about ELIOS during the years it has been available in Europe,” said Yehia Hashad, MD, executive vice president of R&D and chief medical officer for Bausch + Lomb, in the release. “Achieving meaningful reductions in intraocular pressure and freedom from medication for a majority of patients speaks to the promise of this technology. We look forward to sharing the full dataset with the broader ophthalmic community.”

The prospective, multicenter study enrolled 318 patients across 20 US sites. Participants had mild to moderate primary open-angle glaucoma and cataracts and were taking glaucoma medications. The study evaluated 2 co-primary effectiveness endpoints: the percentage of patients achieving at least a 20% reduction in IOP and mean IOP reduction.¹

According to the company, the ELIOS system met both co-primary endpoints, demonstrating statistically significant and clinically meaningful reductions in IOP. Unmedicated diurnal IOP was reduced by at least 20% in 76% of patients, and patients experienced an average decrease of 7.4 mmHg. At 23 months, 82% of patients were medication-free. No intraoperative complications were reported during the procedure, and postoperative adverse event rates were reported to be similar to cataract surgery alone.¹

“The ELIOS procedure shows exciting potential for minimally invasive glaucoma treatment in the US, leveraging precision excimer laser technology to enhance the eye’s natural outflow pathways,” said Mark J. Gallardo, MD, Glaucoma Fellowship Director at El Paso Eye Surgeons, in the release. “I believe glaucoma and cataract specialists alike will be very interested in the consistency of these impressive results as well as the demonstrated strong safety profile.”

The company said the topline results will be discussed during a Bausch + Lomb R&D Teach-in Webinar, and detailed findings will be submitted to a future medical meeting and a peer-reviewed journal.¹

The ELIOS procedure is a minimally invasive glaucoma approach designed to create microchannels in the trabecular meshwork to improve aqueous outflow and reduce IOP. The system has been available in Europe for several years, with data published in 12 clinical studies involving more than 850 treated eyes. Reported outcomes include IOP reductions of 20% to 40% from baseline, reduced medication use for up to four years, and up to 81% of patients medication-free at one year, along with a favorable safety profile.¹

Bausch + Lomb noted that minimally invasive glaucoma surgery (MIGS) procedures have expanded treatment options for mild to moderate glaucoma in Europe and may serve as an alternative to more invasive incisional procedures in the United States.¹

Reference:

1. Bausch + Lomb announces positive 24-month US data on the ELIOS™ System for treatment of glaucoma. News release. Bausch + Lomb. March 23, 2026. Accessed March 23, 2026. https://www.bausch.com/newsroom/news/?id=319