Transcend Medical said today that it filed the final module in its pre-market approval application with the FDA for the CyPass micro-stent glaucoma treatment.
Menlo Park, Calif.-based Transcend said the PMA bid is based on its Compass trial, which met its primary endpoint of 20% or greater reduction in intraocular pressure. The 500-patient study of subjects with mild to moderate glaucoma compared CyPass plus cataract surgery with cataract surgery alone.
“We are very pleased to have attained this important milestone and have the CyPass micro-stent be the next [minimally invasive glaucoma surgery] technology submitted to FDA for premarket approval,” president & CEO Brian Walsh said in prepared remarks. “With the robust results from the Compass study, we believe the CyPass technology can provide a compelling treatment option for mild-to-moderate glaucoma patients undergoing cataract surgery.”
CyPass is designed to be implanted in the supraciliary space to help drain ocular fluid and reduce pressure within the eye. Transcend said the Compass trial also met its secondary endpoints with “statistically significantly greater effectiveness” than cataract surgery alone.