FDA/AGS Workshop on Supporting Innovation for Safe and Effective Minimally Invasive Glaucoma Surgery, February 26, 2014

The Food and Drug Administration (FDA) is announcing the following co-sponsored public workshop entitled “FDA/American Glaucoma Society (AGS) Workshop on Supporting Innovation for Safe and Effective Minimally Invasive Glaucoma Surgery.”

The purpose of this workshop is to address the current challenges in the assessment of implantable minimally invasive glaucoma surgical (MIGS) devices with a focus on clinical trial design and conduct. Glaucoma experts will present evidence to better define the appropriate patient population, as well as the appropriate evaluation of effectiveness and safety for MIGS devices.  The primary goal of the workshop is to determine the best clinical trial design for MIGS devices in order to facilitate bringing these innovative technologies to the US marketplace.

This meeting will be held February 26, 2014, beginning at 1:00 p.m. – 6:00 p.m. (materials may be picked up starting at 12:00 p.m.) at the following location:

Washington Marriott at Metro Center
775 12th Street, NW
Washington, DC, 20005.

This workshop will not be available by Webcast.

1:00pm-1:03pm
Welcome Goals-AGS-Kuldev Singh, MD
1:03pm-1:08pm
Welcome Goals-FDA-Malvina Eydelman, MD

SESSION 1:  Overview of MIGS procedures

PARTICIPANTS
Marlene R. Moster, MD / Thomas W. Samuelson, MD
Marlene R. Moster, MD, Brian A. Francis, MD, Reay H. Brown, MD, Steven D. Vold, MD, Steven R. Sarkisian, Jr., MD,  Thomas W. Samuelson, MD
FDA: Tina Kiang, PhD, Eva Rorer, MD
1:08pm-1:13pm
Leaving the Past Behind: Why We are Looking Forward to MIGS
1:13pm-1:20pm
Non-implantable MIGS Procedures
1:20pm-1:27pm
Implantable MIGS Devices-Canal Based
1:27pm-1:34pm
Implantable MIGS Devices-Suprachoroidal Space
1:34pm-1:41pm
Implantable MIGS Devices-Subconjunctival Space
1:41pm-1:53pm
FDA’s Regulation of Glaucoma devices
1:53pm-2:05pm
ANSI Standard for Implantable Glaucoma Devices:  A framework for clinical evaluation
2:05pm-2:10pm
Working Definition of MIGS and Panel Ground Rules

SESSION 2:  Defining the Patient Population for Implantable MIGS Devices

PARTICIPANTS
David S. Friedman, MD / Richard A. Lewis, MD
Henry D. Jampel, MD, MHS, Donald L. Budenz, MD, MPH, Husam Ansari, MD, PhD Rohit Varma, MD, MPH,  Brian E. Flowers, MD
2:10pm-2:17pm
How to Classify Disease Severity in Clinical Trials of New Glaucoma Surgical Procedures
2:17pm-2:24pm
Severity Cutoff for Study inclusion and Associated Clinical Correlates
2:24pm-3:20pm
PANEL DISCUSSION
3:20pm-3:40pm
BREAK

SESSION 3:  Safety Endpoints Adverse Events

PARTICIPANTS
Richard K. Parrish II, MD / Jeffrey M. Liebmann, MD George L. Spaeth, MD, Dale K. Heuer, MD, Cynthia G. Mattox, MD,  James D. Brandt, MD, Gregory L. Skuta, MD, Douglas J. Rhee, MD, Leon W. Herndon, Jr., MD
3:40pm-3:47pm
Hypotony As An Adverse Outcome of MIGS
3:47pm-3:54pm
Substantial Increase in IOP Versus Baseline
3:54pm-4:02pm  
Substantial Visual Field Loss
4:02pm-4:50pm  
PANEL DISCUSSION

SESSION 4:  Effectiveness Endpoints

PARTICIPANTS
Joseph A. Caprioli, MD / Ronald Leigh Fellman, MD
Thomas W. Samuelson, MD, Malik Y. Kahook, MD Paul Harasymovycz,MD, FRCSC,  Robert J. Noecker, MD,  David L. Epstein, MD, L. Jay Katz, MD, Murray A. Johnstone, MD
4:50pm-5:00pm
The Anatomical and Physiologic Basis for Outflow Surgery Effectiveness:  What Can We Expect?
5:00pm-5:05pm
Selection of Effectiveness Endpoints and Targets:  What Do We Need to Show?
5:05pm-5:10pm
Composite Safety and Effectiveness Endpoints:  Are They Necessary to Measure Device Trial Success?
5:10pm-6:00pm
PANEL DISCUSSION
6:00pm-6:04pm
Concluding Remarks: AGS and FDA
Kuldev Singh, MD, MPH / Malvina B. Eydelman, MD