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
Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.