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FDA, AGS workshop yields consensus recommendations
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WASHINGTON — Panels of glaucoma specialists concurred here that only 1 year of follow-up is needed to assess safety endpoints in studies of minimally invasive glaucoma surgery devices.
“The overwhelming majority of complications are going to occur promptly, so yes, I think a year is enough,” panelist George L. Spaeth, MD, said, agreeing with all other panelists at the joint workshop of the American Glaucoma Society and the U.S. Food and Drug Administration convened to advance the science of MIGS device implantation.
The FDA is “listening carefully,” Malvina B. Eydelman, MD, said of the FDA’s initiative to translate input into its considerations for the approval process for MIGS devices.
Malvina B. Eydelman
“When it comes to minimally invasive glaucoma surgery devices, we still have more questions than we have answers,” Eydelman said. There is a lack of consensus of many aspects of MIGS devices, including the definition of MIGS itself, as well as endpoints and targets, she said.
“There is a lack of FDA guidance or recognized standard, and therefore we cannot clearly delineate safety and effectiveness endpoints for investigation of these devices, and we end up holding extensive discussions with each individual sponsor. What we would like to do is to be able to provide industry with a predictable, consistent, transparent and efficient regulatory pathway that will allow us to facilitate medical device innovation ,” Eydelman said.
“I think we all like the idea of mild, moderate, severe [definitions of] glaucoma, and there may be some ability to tighten up those definitions,” David S. Friedman, MD, MPH, PhD, said, addressing the question of what populations to include in clinical trials. A majority also feels that some objective measure of the optic nerve would be a requirement if field loss is not a requirement for study enrollment, he said.
Joseph A. Caprioli, MD, summed up other points that panelists agreed should be incorporated into clinical trials for MIGS devices: After washout, procedures should have, on average, 20% reduction of pressure, composite measures are desirable, and quality of life measures should also be included.
Joseph A. Caprioli
Disclosures: Caprioli is a consultant for Allergan and receives grant support from Allergan, Alcon and New World Medical. Eydelman is the director of the FDA’s Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office and Device Evaluation Center of Devices and Radiological Health. Friedman is a consultant to Allergan, Alcon, Merck, Quark, Foresight V, Nidek, Valeant and Carl Zeiss Meditec and receives research support from the National Eye Institute and Icare. Spaeth receives research support from the Centers for Disease Control and Prevention.