Transcend Medical Announces Intent to File Premarket Approval Application With FDA for the CyPass(R) Glaucoma Micro-Stent
Pivotal COMPASS Trial Reveals Positive Results Through Two Years for Novel Micro-Stent
(firmenpresse) - MENLO PARK, CA -- (Marketwired) -- 05/05/15 -- Transcend Medical, Inc. announced today its intent to file a premarket approval (PMA) application with the U.S. Food and Drug Administration (FDA) for the CyPass® Micro-Stent, a novel minimally invasive glaucoma surgical (MIGS) implant. The company recently completed the COMPASS pivotal trial evaluating the device, demonstrating sustained and consistent positive results through two years. Transcend Medical expects to file the PMA application with FDA in the second half of 2015.
The COMPASS study's primary endpoint was met, demonstrating that implantation of the CyPass Micro-Stent with cataract surgery resulted in a 20% or greater reduction in intraocular pressure (IOP) from medication-free baseline in a statistically significantly higher proportion of eyes compared to cataract surgery alone at both the two- and one-year medication-free postoperative examinations. In addition, all secondary endpoints showed statistically significantly greater effectiveness of the CyPass Micro-Stent plus cataract surgery versus cataract surgery alone. Along with device effectiveness, safety was rigorously monitored over the two-year follow-up period.
"The CyPass Micro-Stent represents the next wave of innovation in the MIGS category," said Dr. Steven Vold, MD, President of Vold Vision (Fayetteville, Arkansas), Chair of the COMPASS Steering Committee, and one of the lead investigators for the study. "It is encouraging to see the COMPASS results validated through such a large, robust pivotal study. With an elegant, straightforward implantation procedure coupled with these positive clinical outcomes, the CyPass Micro-Stent is positioned to provide a valuable new therapeutic option for ophthalmologists treating their cataract patients suffering from glaucoma."
The COMPASS study was a prospective, multicenter, randomized, controlled trial conducted at more than 20 sites throughout the U.S. under an Investigational Device Exemption (IDE) as part of the PMA requirements for the CyPass Micro-Stent. Over 500 patients with mild-to-moderate glaucoma undergoing cataract surgery were randomized to either receive the CyPass Micro-Stent after cataract surgery or undergo no further intervention.
"We are very pleased with the results of the COMPASS trial," said Brian Walsh, President and Chief Executive Officer of Transcend Medical. "We are committed to a rigorous, evidence-based approach to evaluating the CyPass Micro-Stent, and the COMPASS study is a testament to this mission. We believe the CyPass technology has the potential to help the millions of patients who suffer from glaucoma worldwide, and we look forward to FDA's review of our PMA submission."
The CyPass Micro-Stent is the first minimally invasive glaucoma stent designed to reduce intraocular pressure (IOP) by enhancing aqueous outflow to the suprachoroidal space. Implanted using a minimally invasive procedure, the CyPass Micro-Stent avoids the trabecular meshwork and Schlemm's canal -- a drainage pathway that is believed to be compromised in glaucomatous eyes. The CyPass Micro-Stent has received the CE Mark and is currently under investigation for mild-to-moderate glaucoma the U.S. in the COMPASS Clinical Study.
Transcend Medical () is a privately-held, venture-backed medical device company focused on the development of minimally invasive glaucoma interventions for the ophthalmic surgeon. Glaucoma is the leading cause of adult irreversible blindness, with nearly 6 million in the U.S. and over 70 million worldwide affected by the disease today. Glaucoma is a progressive disease of the optic nerve, usually the result of abnormally high intraocular pressure (IOP). While topical medications to lower IOP are considered first-line therapy and represent a more than $5 billion market,(1) patient adherence is low,(2) and many require alternative therapies.
Caution: Investigational Device. Limited by Federal (U.S.) law to investigational use.
(1) Market Scope. 2012 Report on the Global Glaucoma Surgical Device Market. September 2012.
(2) Muir KW. Glaucoma medication adherence: room for improvement in both performance and measurement. Arch Ophthalmol 2011 Feb;129(2):243-5.
CyPass is a registered trademark, and Transcend is a trademark, of Transcend Medical, Inc.
For more information, please contact:
Ravi Pamnani
Transcend Medical, Inc.
+1-650-223-6625
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Datum: 05.05.2015 - 10:00 Uhr
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