PURPOSE: The ELIOS system (Bausch + Lomb) is the first clinically validated excimer laser trabecular bypass minimally invasive glaucoma surgery (MIGS). This trial evaluated the effectiveness and safety of the MIGS system to reduce intraocular pressure (IOP) in adults with mild-to-moderate primary open-angle glaucoma (POAG) undergoing cataract surgery.

METHODS: This was a prospective, non-randomized 24-month clinical trial at 20 sites in the USA (NCT04899063). Patients were aged ≥45 years with mild-to-moderate POAG, an operable age-related cataract eligible for phacoemulsification with best-corrected visual acuity of 20/40 or worse, medicated IOP of ≤24 mmHg and unmedicated diurnal IOP (DIOP) of 22–34 mmHg. Patients meeting all inclusion criteria underwent the MIGS procedure after uncomplicated cataract surgery. The co-primary effectiveness endpoints were the proportion of patients achieving a decrease in medication-free mean DIOP of ≥20%, and mean change in medication-free DIOP, from baseline at 12 months. Safety was assessed throughout the trial.

RESULTS: A total of 318 patients underwent the procedure (mean±standard deviation [SD] age 70.2±7.4 years). Mean±SD medicated IOP at screening was 17.05±3.01 mmHg and unmedicated DIOP at baseline was 24.53±2.51 mmHg. At Month 12, co-primary effectiveness endpoints were met: 84.2% of patients achieved a ≥20% decrease in unmedicated mean DIOP from baseline (97.5% CI 79.59, 88.84; p=0.0116 vs performance goal of >79%), and mean DIOP change was −8.17 mmHg (97.5% CI −8.65, −7.69; p<0.0001 vs performance goal of 7.2 mmhg. meansd number of medications decreased from 1.50.7 at screening n="318)" to 0.20.7 at month 11 n="298)" with sustained iop reduction throughout follow-up.>

CONCLUSIONS: Both co-primary effectiveness endpoints were met. ELIOS demonstrated clinically meaningful and sustained reduction in unmedicated DIOP in patients with POAG undergoing cataract surgery. Mean IOP reduction of 34.5% at Month 12 aligns with recommended target reduction for mild-to-moderate glaucoma (≥25% reduction to below 17 mmHg).