OSAKA, Japan, July 6, 2020 /PRNewswire/ -- Santen
Pharmaceutical Co., Ltd. (hereinafter, Santen) today 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, a leading cause of
blindness.1,2 The prevalence of POAG is expected to rise
to 4.1 million in 2025.1
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. 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, 8.5-mm-long tube with planar fins to help fixate the
device in the tissue and prevent leakage and migration.
About Santen
As a specialized company dedicated
to ophthalmology, Santen carries out research, development,
marketing, and sales of pharmaceuticals, over-the-counter products,
and medical devices. Santen is the market leader for prescription
ophthalmic pharmaceuticals in Japan and its products now reach patients in
over 60 countries. With scientific knowledge and organizational
capabilities nurtured 130-year history, Santen provides products
and services to contribute to the well-being of patients, their
loved ones and consequently to society. For more information,
please visit Santen's website (www.santen.com).
Santen Forward-looking
Statements
Information provided in this press
release contains forward-looking statements. The achievement of
these forecasts is subject to risk and uncertainty from various
sources. Therefore, please note that the actual results may differ
significantly from the forecasts. Business performance and
financial conditions are subject to the effects of changes in
regulations made by the governments of Japan and other nations concerning medical
insurance, drug pricing and other systems, and to fluctuations in
market variables such as interest rates and foreign exchange
rates.
Contact
Akiko
Yoshikawa
Corporate Communications Group Santen Pharmaceutical Co., Ltd.
E-mail: ir@santen.com Tel. : +81-6-4802-9360
US Contact
Lisa
Her
Corporate Communications Santen, Inc.
E-mail: Lisa.Her@santen.com Tel. :
+1-510-414-8977
1 Kapetanakis VV, Chan MPY, Foster PJ, Cook DG,
Owen CG, Rudnicka AR. Global variations and time trends in the
prevalence of primary open angle glaucoma (POAG): a systematic
review and meta-analysis. Br J Ophthalmol 2016;100:86–93.
2 Glaucoma Research Foundation. Glaucoma Facts
and Stats. Available at
https://www.glaucoma.org/glaucoma/glaucoma-facts-and-stats.php.
Accessed April 8, 2020.
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SOURCE Santen