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FDA, Glaucoma Society to Hold Workshop on Minimally Invasive Surgery

Feb. 3, 2014

The FDA and American Glaucoma Society are co-hosting a public workshop to address challenges in testing implantable minimally invasive glaucoma surgical devices, in light of increasing debate over trial design and safety and effectiveness parameters.

The workshop — slated for Feb. 26 at the Washington Marriott at Metro Center in D.C. — will bring together industry players and academics to evaluate subject enrollment criteria, effectiveness endpoints and safety parameters, the agency says. Discussion topics include:

  • Definition of MIGS and procedural overviews;
  • Definition of the patient population;
  • Determination of effectiveness endpoints for implantable MIGS; and
  • Determination of appropriate safety parameters for these devices.

Glaucoma is the second leading cause of blindness around the world, the agency notes. Read today’s Federal Register notice at www.fdanews.com/ext/resources/files/02/02-03-14-Glaucoma.pdf. — Lena Freund

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