Bausch + Lomb (NYSE:BLCO) today unveiled positive topline results from its pivotal 24-month U.S. clinical trial of the ELIOS System, an innovative, implant-free procedure designed to treat elevated intraocular pressure (IOP) in patients with open-angle glaucoma.
The data, presented during the company’s inaugural R&D Teach-in Webinar, suggests ELIOS could significantly disrupt the minimally invasive glaucoma surgery (MIGS) market by leveraging next-generation excimer laser technology to enhance the eye’s natural drainage pathways.
The prospective, multicenter study followed 318 patients across 20 U.S. sites who were diagnosed with mild-to-moderate primary open-angle glaucoma and cataracts.
The system successfully met both co-primary effectiveness endpoints, demonstrating statistically significant and clinically meaningful reductions in DIOP (diurnal intraocular pressure).
Specifically, 76% of patients achieved a 20% or greater reduction in unmedicated DIOP, with an average decrease of 7.4 mmHg.
Perhaps most significantly for patient quality of life, 82% of participants remained medication-free at the 23-month mark.
This high rate of pharmaceutical independence addresses a major hurdle in glaucoma management: patient compliance with daily eye drops.
From a safety perspective, the ELIOS procedure showed no intraoperative complications and a postoperative adverse event rate comparable to undergoing cataract surgery alone, highlighting its precision and minimal tissue trauma.
While ELIOS already carries a CE mark in Europe, it remains an investigational device in the United States.
Dr. Yehia Hashad, Chief Medical Officer at Bausch + Lomb, noted that these "strong U.S. results reinforce everything learned during the years it has been available in Europe."
The company plans to submit the full dataset to the FDA for review and present detailed findings at upcoming medical congresses.