Bausch + Lomb's ELIOS System Achieves Primary Endpoints in 24-Month U.S. Glaucoma Trial
核心洞察
Bausch + Lomb (搜索)'s ELIOS System (搜索) met both co-primary effectiveness endpoints in a pivotal U.S. clinical trial, demonstrating statistically significant and clinically meaningful intraocular pressure reduction in glaucoma (搜索) patients.
The implant-free excimer laser procedure achieved a 20% or greater reduction in unmedicated diurnal IOP in 76% of patients, with 82% remaining medication-free at 23 months.
The 318-patient multicenter study showed an average 7.4 mmHg decrease in unmedicated diurnal IOP with no intraoperative complications and a safety profile similar to cataract surgery alone.
Bausch + Lomb (搜索) Corporation has announced positive 24-month results from its pivotal U.S. clinical trial of the ELIOS System (搜索), an implant-free excimer laser procedure for treating elevated intraocular pressure in patients with open-angle glaucoma (搜索). The prospective, multicenter study met both co-primary effectiveness endpoints, demonstrating statistically significant and clinically meaningful IOP reduction in 318 enrolled patients.
Trial Design and Patient Population
Investigators at 20 sites across the United States enrolled patients taking glaucoma (搜索) medications who were previously diagnosed with mild to moderate primary open-angle glaucoma (搜索) as well as cataracts (搜索). The study evaluated two co-primary effectiveness endpoints: the percentage of patients achieving at least a 20% reduction in IOP and mean IOP reduction.
Key Clinical Outcomes
The ELIOS system (搜索) demonstrated robust efficacy across multiple measures. Unmedicated diurnal IOP was reduced by 20% or greater in 76% of patients, while patients experienced an average 7.4 mmHg decrease in unmedicated diurnal IOP. Notably, 82% of patients remained medication-free at 23 months, indicating sustained therapeutic benefit.
"These strong U.S. 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, R&D and chief medical officer at Bausch + Lomb (搜索). "Achieving meaningful reductions in intraocular pressure and freedom from medication for a majority of patients speaks to the promise of this technology."
Safety Profile
The procedure demonstrated a favorable safety profile with no intraoperative complications observed during the ELIOS procedure. The postoperative adverse event rate was similar to cataract surgery alone, supporting the minimally invasive nature of the treatment approach.
Mark J Gallardo, MD, Glaucoma (搜索) Fellowship Director at El Paso Eye Surgeons, commented on the clinical significance: "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. 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."
Technology and Mechanism
The ELIOS procedure uses excimer laser technology to create microchannels in the trabecular meshwork (搜索), facilitating aqueous outflow and reducing intraocular pressure. This implant-free approach represents a minimally invasive alternative to more invasive incisional procedures such as trabeculectomy and tube shunts.
European Experience and Broader Context
ELIOS has been available in Europe for several years, with data published in 12 clinical studies involving more than 850 treated eyes. European studies have shown IOP reduction of 20-40% from baseline, significant medication reduction for up to four years, and up to 81% of patients achieving medication-free status at one year, with a favorable safety profile.
Over the past decade, minimally invasive glaucoma (搜索) surgeries (MIGS) have transformed the treatment of mild to moderate glaucoma in Europe and have the potential to serve as attractive alternatives to more invasive procedures in the United States.
Regulatory Status and Next Steps
ELIOS is currently under development in the United States and has not been reviewed by the U.S. Food and Drug Administration for safety or effectiveness. The system is currently CE marked in Europe. Detailed results from the pivotal trial will be submitted to a future medical meeting and a peer-reviewed journal.