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IMG_Jul72020at105029AM.jpg Michail Petrov

FDA Accepts Santen’s PMA Application for MIGS Device

The Osaka, Japan-based company gained access to the DE-128 device when it acquired Innfocus for about $225 million in 2016.

The needle is moving a bit for Santen Pharmaceutical’s device to help treat glaucoma. The Osaka, Japan-based company said FDA has accepted the PMA application for DE-128 (MicroShunt).

DE-128 is an investigational, ab-externo, minimally-invasive surgical glaucoma implant designed to help drain eye fluid and reduce intraocular pressure (IOP) in patients with primary open-angle glaucoma (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.

The device sits firmly in the minimally invasive glaucoma surgery (MIGS) space. Santen gained access to DE-128 and the market when it acquired Miami, FL-based Innfocus for about $225 million in 2016.

Glaukos, the biggest player in the MIGS market, received approval for the iStent in 2012.  

Earlier this year, Santen and Verily Life Sciences formed a joint venture to develop digital ophthalmology technology.

The joint venture combined Santen’s industry knowledge and technology in ophthalmology with Verily’s expertise in the development of connected, integrated medical devices and machine learning.

TAGS: Technologies
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