■ Iqbal Ike K. Ahmed, MD, presented data from the FDA pivotal study of the newly approved iStent infinite (Glaukos) at ASCRS 2023 in San Diego. The patients studied were difficult to treat, he noted, defined as having refractory glaucoma with failed previous surgery or on maximal tolerated medical therapy (MTMT). Dr. Ahmed is director of the Alan S. Crandall Center for Glaucoma Innovation at the John A. Moran Eye Center of the University of Utah.
Among the 70 patients, 61 failed prior surgery, Dr. Ahmed noted. Many had moderate to advanced disease, and the patients that were at MTMT were on an average of 4 or more medications. The primary outcome of 20% reduction was achieved in 76% of patients; 93% maintained or reduced their medication use, and 53% achieved ≥30% reduction in IOP on the same or fewer medications.
Average baseline pressure of 23.5 mmHg reduced to around 16.6 mmHg, he said, with average medication use down to about 2.7 from 3.1. The change in IOP results were significantly different between the failed surgery group and the MTMT group.
“The MTMT group, which is probably more where this device will be used eventually, had more favorable results, about a 35% drop vs about a 20% drop in the failed surgery group,” Dr. Ahmed said.