VAUGHAN, Ontario — Bausch + Lomb Corp. announced positive 24-month results from the pivotal U.S. clinical trial of the ELIOS System. Developed for the treatment of elevated intraocular pressure (IOP) in patients with open angle glaucoma, ELIOS is an implant-free procedure that uses next generation excimer laser technology. The ELIOS procedure is currently CE marked in Europe and is under development and has not been reviewed by the FDA for safety and efficacy in the United States.
“These strong U.S. study results reinforce everything we’ve learned about ELIOS during the years it has been available in Europe,” said Dr. Yehia Hashad, executive vice president, R&D and chief medical officer, Bausch + Lomb. “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.”
In the prospective, multicenter study, investigators at 20 sites across the U.S. enrolled 318 patients taking glaucoma medications. Patients were previously diagnosed with mild to moderate primary open-angle glaucoma as well as cataracts. Two co-primary effectiveness endpoints were evaluated: the percentage of patients achieving at least a 20% reduction in IOP, and mean IOP reduction.
The ELIOS system met the study’s co-primary effectiveness endpoints, demonstrating both statistically significant and clinically meaningful IOP reduction. Key results included:
- Unmedicated diurnal IOP (DIOP) was reduced by 20% or greater in 76% of patients
- Patients experienced an average of 7.4 mmHg decrease in unmedicated DIOP
- 82% of patients were medication-free at 23 months
- No intraoperative complications seen during the ELIOS procedure
- Similar postoperative adverse event rate as cataract surgery alone
“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,” said Dr. Mark J Gallardo, Glaucoma Fellowship Director at El Paso Eye Surgeons. “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.”
These topline results will be discussed at 1:30 p.m. ET today during the inaugural Bausch + Lomb R&D Teach-in Webinar (register here). Detailed results from the pivotal trial will be submitted to a future medical meeting and a peer-reviewed journal.
