Transcend Medical yesterday said it plans to file for pre-market approval from the FDA for its CyPass glaucoma micro-stent after its Compass clinical trial showed "sustained and consistent positive results through 2 years."
Menlo Park, Calif.-based Transcend said it plans to file for the PMA during the 2nd half of the year, noting that the Compass trial met its primary endpoint of 20% or greater reduction in intraocular pressure. The Compass trial, of more than 500 patients with mild to moderate glaucoma, compared CyPass plus cataract surgery with cataract surgery alone.
"The results are positive and highly statistically significant across all endpoints at both 1 and 2 years," marketing & medical affairs director Ravi Pamnani told MassDevice.com via email, noting that CyPass is the 1st minimally invasive glaucoma stent to achieve this milestone.
"We are planning on releasing the detailed data, as well as submitting to peer-reviewed publications, following our PMA application to FDA later this year," Pamnani wrote.
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.
"We are very pleased with the results of the Compass trial," president & CEO Brian Walsh said in prepared remarks. "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 represents the next wave of innovation in the MIGS category," added co-lead investigator Dr. Steven Vold of Vold Vision in Fayetteville, Ark. "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."
