Bausch + Lomb announced positive 24-month topline results from the pivotal US clinical trial of the ELIOS System, an implant-free, minimally invasive procedure that uses excimer laser technology to lower IOP in patients with open-angle glaucoma. According to the company, the prospective, multicenter study enrolled 318 patients with mild to moderate primary open-angle glaucoma and cataracts who were taking glaucoma medications at 20 US sites.

The company said the ELIOS System met both coprimary effectiveness endpoints, demonstrating statistically significant and clinically meaningful IOP reduction. At 24 months, 76% of patients achieved a 20% or greater reduction in unmedicated diurnal IOP, and the mean decrease in unmedicated diurnal IOP was 7.4 mm Hg. Additionally, 82% of patients were medication-free at 23 months.

Bausch + Lomb also reported no intraoperative complications during the ELIOS procedure and a postoperative adverse event rate similar to cataract surgery alone. The company said detailed results from the pivotal trial will be submitted to a future medical meeting and a peer-reviewed journal.

The ELIOS procedure is CE marked in Europe. In the United States, the system remains under development and has not been reviewed by the FDA for safety or effectiveness.