Transcend Medical, Inc.
Transcend Medical, Inc., a pioneer of minimally invasive glaucoma surgery (MIGS), today announced the submission to the U.S. Food and Drug Administration (FDA) of the final module of the company’s Premarket Approval (PMA) application for the CyPass® Micro-Stent.
The CyPass Micro-Stent is a MIGS implant designed to reduce intraocular pressure (IOP) in patients with primary open-angle glaucoma. The final module includes two-year patient follow-up data from the COMPASS pivotal clinical trial, in which more than 500 patients in over 20 sites throughout the U.S. were enrolled, making it the largest completed, randomized, controlled trial in the field of MIGS. In the study, the CyPass Micro-Stent demonstrated superiority over the control by achieving both primary and secondary endpoints at one and two years.
“We are very pleased to have attained this important milestone and have the CyPass Micro-Stent be the next MIGS technology submitted to FDA for premarket approval,” said Brian Walsh, President and Chief Executive Officer of Transcend Medical. “With the robust results from the COMPASS study, we believe the CyPass can provide a compelling treatment option for mild-to-moderate glaucoma patients undergoing cataract surgery.”
About the CyPass® Micro-Stent
The CyPass Micro-Stent is the first minimally invasive glaucoma stent designed to reduce 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 was the subject of investigation for the treatment of mild-to-moderate glaucoma the U.S. in the COMPASS Clinical Study.
About the COMPASS study
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 adult 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