Butchertown Clinical Trials and The Eye Care Institute Announce Our 17th FDA Approval or Clearance
LOUISVILLE, KENTUCKY, UNITED STATES, January 24, 2023 /EINPresswire.com/ — Visant Medical, a Menlo Park, CA company, announced FDA Clearance for its patented canalicular occlusive device. The device blocks tear drainage through the canalicular system in patients experiencing both signs and symptoms of dry eye disease for up to six months.
John C. Meyer, MD, of The Eye Care Institute and Butchertown Clinical Trials, was the principal investigator for the proof of concept research leading to the clinical trials being submitted to the FDA for clearance of this novel approach to treating signs and symptoms of dry eye disease. “Designers brought several prototypes of the device to our facility. I was able to implant several versions of the prototype to determine which was most effective in meeting the scientific goals. Even in the early stages of development, it was clear this device was headed for success,” Meyer said.
“We are pleased to have received FDA clearance for our innovative dry eye product, which is based on a proprietary formulation of cross-linked hyaluronic acid,” said Vartan Ghazarossian, Ph.D., Co-founder, President, and CEO of Visant Medical. “Upon commercialization, the product will be offered as a kit that includes the device in a sterile syringe, along with compatible cannulas for delivery of the device.”
Mark Prussian, CEO of Butchertown Clinical Trials and The Eye Care Institute, said, “I recall that when Dr. Ghazarossian came to my office, he was laser-focused on engineering and design of this device. Together, we compared retail hyaluronic acid, which my wife, Betsy Prussian, purchased at a local Trader Joe’s, with the large quantities his firm was buying for research and development.”
This is the 17th FDA approved or cleared drug or device for Louisville, KY based Butchertown Clinical Trials. Three additional drugs or devices researched at Butchertown Clinical Trials are currently before the FDA awaiting approval.
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For More Information, Contact Mark Prussian at Butchertown Clinical Trials