■ Santen Pharmaceutical announced positive 1-year results of a prospective, randomized, controlled, single-masked, multicenter study to assess the safety and effectiveness of DE-128 (MicroShunt) standalone, without concomitant cataract extraction. The study compared DE-128 implanted intraoperatively with a 0.2 mg/mL concentration of mitomycin C (MMC) against standard of care trabeculectomy with the same concentration of MMC.
“We are delighted to have completed this first US premarket approval, head-to-head study of MicroShunt against trabeculectomy in glaucoma subjects who could benefit from a surgical device that uses a standardized, effective, standalone and less cumbersome surgical procedure to produce predictable outcomes,” said Naveed Shams MD, PhD, head of Santen’s Global R&D, in a news release.
The data demonstrated that the mean (±SD) diurnal IOP at month 12 in the DE-128 arm dropped from medicated 21.1±4.9 mmHg to 14.2±4.4 mmHg, and in the trabeculectomy arm, mean diurnal IOP dropped from 21.1±5.0 mmHg to 11.2±4.2 mmHg. The mean number of glaucoma medications used per patient was reduced in both groups, from an average of 3.0 medications at screening to 0.6 in the DE-128 group and 0.3 in the trabeculectomy arm at month 12. In the DE-128 arm, 71.6% of subjects were medication free at month 12, and 84.8% were medication free at month 12 in the trabeculectomy arm.
Suture lysis was required to decrease IOP in the trabeculectomy arm and not in the DE-128 arm (52.3% vs 0%, respectively), and the rate of hypotony at any time was 51.1% in the DE-128 arm and 30.6% in the trabeculectomy arm.
“Although the IOP-lowering effect of trabeculectomy (11 mmHg) was statistically superior than that of the MicroShunt, the trabeculectomy arm had a greater incidence of hypotony, bleb leaks, and lens opacity, complications typically associated with trabeculectomy,” said study medical monitor Paul Palmberg, MD, PhD, of the Bascom Palmer Eye Institute, in a news release.