A collaborative effort among the FDA, bicoastal Centers of Excellence and Regulatory Science and Innovation (CERSI), and the American Glaucoma Society (AGS) has completed a project to determine patient preferences in glaucoma treatment with a focus on minimally invasive glaucoma surgery devices.
Reviewed by Malvina Eydelman, MD, and George L. Spaeth, MD
IN 2013, the FDA launched a collaborative project that recognized the value of including information from glaucoma patients in the agency’s evaluation of minimally invasive glaucoma surgical (MIGS) devices. The project involves participation of the FDA, the bicoastal Centers of Excellence and Regulatory Science and Innovation (CERSI) at University of California San Francisco-Stanford University and Johns Hopkins University, and the American Glaucoma Society (AGS).
Speaking at the AGS meeting in March, Malvina Eydelman, MD, announced that one goal of the dual-armed program has been completed and the second has entered its final phase.
“We, at the FDA, believe that patients’ input can and should inform medical device development and evaluation throughout the product life cycle,” said Dr. Eydelman, director, Division of Ophthalmic, and Ear, Nose and Throat Devices, Center for Devices and Radiologic Health, U.S. FDA, Silver Spring, MD.
“Along with that concept, we published two guidance documents defining how patient preference information and patientreported outcomes can be utilized to assess the safety and effectiveness of new medical devices.
“We have been fortunate to obtain funding from the FDA to allow collaboration between the bicoastal CERSI in this program and to work with the AGS that has been a significant contributor since the project’s inception,” she added.