A multicenter study found the DE-128 microshunt implanted intraoperatively with 0.2 mg/mL concentration of mitomycin C effectively reduced IOP in patients with primary open-angle glaucoma not controlled with maximum tolerated glaucoma medications, Santen Pharmaceutical announced in a press release.
The INN-005 prospective, randomized, controlled, single-masked study compared patients who received DE-128 implanted intraoperatively with 0.2 mg/mL concentration of MMC against the standard of care of trabeculectomy with the same concentration of MMC.
Patients implanted with DE-128 experienced a mean diurnal IOP reduction from 21.1 ± 4.9 mm Hg to 14.2 ± 4.4 mm Hg at month 12 compared with a reduction from 21.1 ± 5 mm Hg to 11.2 ± 4.2 mm Hg in the trabeculectomy group, according to the release.
The mean number of glaucoma medications decreased in both groups, from an average of three medications at screening to 0.6 in the DE-128 group and 0.3 in the trabeculectomy group. At month 12, 71.6% of DE-128 patients were medication-free compared with 84.8% in the trabeculotomy arm.
No patients in the DE-128 arm required suture lysis to decrease IOP compared with 52.3% in the trabeculectomy arm. The rate of hypotony was 51.1% in the trabeculectomy arm compared with 30.6% in the DE-128 arm.