Santen Pharmaceutical Co., Ltd. has announced that the U.S. Drug Administration (FDA) will review its Premarket Approval (PMA) application for the investigational surgical glaucoma implant DE-128 (MicroShunt) designed to reduce intraocular pressure (IOP).
In the United States, DE-128 is an ab-externo, minimally-invasive implant designed to help drain eye fluid and reduce IOP in patients with primary open-angle glaucoma (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. DE-128 is a flexible, 8.5-mm-long tube made of a proprietary, biocompatible material called SIBS [poly(styrene-block-isobutylene-block-styrene)], and is built with planar fins to help fixate the device in the tissue and prevent leakage and migration.
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.
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.
Full press release: https://www.santen.com/en/news/
Source: Santen Pharmaceutical