FDA, AGS workshop yields consensus recommendations

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, (Read more...)