07.07.20

Santen Announces FDA Acceptance of Premarket Approval Application for DE-128 (MicroShunt) for Review

Source: Santen

Santen Pharmaceutical announced that the 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 IOP in patients with primary open-angle glaucoma whose IOP is not controlled when using maximum tolerated glaucoma medications. 

The review of the PMA traditionally spans 180 days.

As of this year, it is expected that 3.7 million people in America will be living with POAG, a leading cause of blindness. The prevalence of POAG is expected to rise to 4.1 million in 2025.

About DE-128 (MicroShunt) 

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. Made of a proprietary, biocompatible material called SIBS [poly(styrene-block-isobutylene-block-styrene)], DE-128 is a flexible, 8.5-mm-long tube with planar fins to help fixate the device in the tissue and prevent leakage and migration. 

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