FDA accepts premarket approval application for DE-128
The FDA has accepted the premarket approval application for Santen Pharmaceutical’s DE-128 microshunt for review, according to a press release.
The ab-externo MIGS device is intended for reduction of IOP in patients with primary open-angle glaucoma whose disease is not well controlled using maximum tolerated glaucoma medications.
In a previously reported multicenter study, the microshunt reduced mean diurnal IOP reduction from 21.1 mm Hg to 14.2 mm Hg at month 12 compared with a reduction from 21.1 mm Hg to 11.2 mm Hg in a standard of care trabeculectomy group. Number of medications were reduced in both groups, and no patients in the DE-128 arm required suture lysis. The rate of hypotony in the microshunt arm was less than in the trabeculectomy arm.
An FDA decision is expected in about 6 months.