FDA acceptance of PMA application
Santen has announced that the United States Food and Drug Administration (FDA) has accepted the Premarket Approval (PMA) application for DE-128 (MicroShunt) for review. DE-128 is an investigational surgical glaucoma implant designed to reduce intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG) whose IOP is not controlled when using maximum tolerated glaucoma medications.
The substantive review, which traditionally spans 180 days from the FDA’s receipt of the PMA final module, is an in-depth review following which the FDA will make a decision as to whether the PMA is approved.
“As of this year, it is expected that 3.7 million people in America will be living with POAG,” said a Santen spokeswoman. “The prevalence of POAG is expected to rise to 4.1 million in 2025,” she said.
In the United States, DE-128 is an investigational, ab-externo, minimally-invasive surgical glaucoma implant designed to help drain eye fluid and reduce IOP in patients with POAG whose IOP is not controlled when using maximum tolerated glaucoma medications. IOP reduction is the most effective means of preventing the progression of glaucoma and vision loss. Made of a proprietary, biocompatible material called SIBS [poly(styrene-block-isobutylene-block-styrene)], DE-128 is a flexible, 8.5mm-long tube with planar fins to help fixate the device in the tissue and prevent leakage and migration.