FORT LAUDERDALE, Fla. — Patient preferences are a part of the regulatory science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of all FDA-regulated products, Malvina B. Eydelman, MD, director of the FDA’s Division of Ophthalmic and Ear, Nose and Throat Devices, said at the American Glaucoma Society meeting.
“Patient preferences is all about weighing the benefits and risks,” she said. “So for a low-benefit, high-risk device, the product may only get approved if significant evidence exists that at least a subset of patients would trade the risk for the benefit.”
Malvina B. Eydelman
At Johns Hopkins University and University of California, San Francisco/Stanford, two of four recently established Centers of Excellence in Regulatory Science and Innovation (CERSI), collaboration with the FDA is underway to determine patient preferences in glaucoma treatment with a focus on minimally invasive glaucoma surgery (MIGS) devices and to begin development of patient-reported outcome measures to assess health-related quality of life in mild to moderate glaucoma patients.
“We are incredibly fortunate to be able to formulate the first bicoastal CERSI collaboration between FDA and Johns Hopkins and UCSF/Stanford,” Eydelman said.
At Johns Hopkins University, the project will aim to determine patient preferences in glaucoma treatment with a focus on MIGS devices. At Stanford, patient-reported outcome measures will be developed to assess health-related quality of life in mild to moderate glaucoma patients. – by Patricia Nale, ELS
Disclosure: Eydelman reports no relevant financial disclosures.