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Transcend Medical Completes Enrollment in Landmark Glaucoma Study Evaluating the CyPass(R) Micro-Stent
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MENLO PARK, CA, Feb 28 (Marketwire) --
Transcend Medical, Inc., a medical device company dedicated to developing
minimally invasive glaucoma interventions for the ophthalmic surgeon,
announced completion of enrollment in the COMPASS Clinical Study
evaluating the CyPass Micro-Stent in combination with cataract surgery
for patients with primary open-angle glaucoma.
"This is an important milestone in the field of glaucoma. The CyPass
device is the first micro-invasive stent designed to enhance
suprachoroidal outflow, a drainage pathway with untapped potential to
reduce intraocular pressure (IOP). Implantation of the CyPass Micro-Stent
is uniquely elegant and straightforward, and the clinical data generated
by our colleagues in Canada and Europe over the last four years has been
very promising," said Dr. Steven Vold, Founder and CEO of Vold Vision
(Fayetteville, AR) and Chairman of the COMPASS Steering Committee. "I am
honored to be a member of the distinguished COMPASS investigational team,
and we look forward to presenting the results upon study completion."
One of the largest glaucoma surgery studies to date, COMPASS is a
prospective, multicenter, randomized, controlled trial conducted at more
than 20 sites in the United States. Over 500 glaucoma patients undergoing
cataract surgery have been randomized to receive either the CyPass
Micro-Stent during cataract surgery or to undergo cataract surgery alone.
The primary effectiveness endpoint for the study is the proportion of
eyes with >20% decrease in IOP from baseline to the medication-free
24-month postoperative examination.
With the completion of COMPASS enrollment, there are now more than 1,000
patients treated with the CyPass Micro-Stent in Transcend's worldwide
clinical development programs.
In the U.S., over 20% of patients undergoing cataract surgery have a
concurrent diagnosis of glaucoma,(1) representing approximately 700,000
patients each year who may be candidates for the investigational
treatment. Currently, antihypertensive eye drops are the first-line
therapy for these glaucoma patients, although adherence to such
treatments is as low as 50% after the first year.(2)
"Micro-invasive glaucoma surgery (MIGS) devices such as the CyPass
Micro-Stent represent important advances as we try to address the problem
of glaucoma. There is much need for new approaches in this field, and in
recent years there has been significant progress at innovative companies
like Transcend," said Dr. H. Dunbar Hoskins, Jr., Clinical Professor,
University of California, San Francisco (San Francisco, CA) and former
executive vice president of the American Academy of Ophthalmology.
"Completion of COMPASS enrollment represents a tremendous effort by both
the company and the investigational sites," said Brian Walsh, President
and CEO of Transcend Medical. "Our team has been laser-focused on
enabling the CyPass Micro-Stent to be the next MIGS device available for
FDA review. When the COMPASS study concludes, the results will provide an
unprecedented level of data regarding the use of a glaucoma micro-stent
in patients undergoing cataract surgery. We are excited to be moving this
technology forward, as we believe the CyPass Micro-Stent has the
potential to improve glaucoma management for millions of patients
worldwide."
About the CyPass(R) Micro-Stent*
The CyPass Micro-Stent is the first micro-invasive glaucoma stent
designed to reduce IOP by enhancing aqueous outflow to the suprachoroidal
space, one of the eye's natural, alternative drainage pathways. Implanted
in the supraciliary space, the CyPass device bypasses the ciliary body by
creating a stented micro-cyclodialysis and enhancing the same outflow
system targeted by prostaglandin analogues, the most effective medical
treatment for IOP. Targeting suprachoroidal outflow bypasses the
trabecular meshwork and Schlemm's canal -- drainage paths that may be
compromised in glaucomatous eyes. While the CE mark for the device was
granted in 2008, the CyPass Micro-Stent is currently for investigational
use only.
About Transcend Medical, Inc.
Transcend Medical (www.transcendmedical.com) is focused on the
development of minimally invasive medical devices for the treatment of
glaucoma, the leading cause of adult irreversible blindness. Over 4
million people in the U.S. and roughly 60 million worldwide are afflicted
with the disease today, and the numbers are expected to grow to nearly 6
million in the U.S. and over 70 million worldwide by the year 2015.
*Caution: Investigational Device. Limited by Federal (USA) law to
investigational use.
(1) Tseng. Risk of fractures following cataract surgery in Medicare
beneficiaries. JAMA. 2012;308(5):493-501.
(2) Vrijens. Adherence to prescribed antihypertensive drug treatments:
longitudinal study of electronically compiled dosing histories. BMJ.
2008;336(7653):1114-1117.
For more information, please contact:
Ravi Pamnani
Transcend Medical, Inc.
+1-650-223-6625
rpamnani@transcendmedical.com
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