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 – 1:03 pm||Welcome & Goals AGS||Kuldev Singh, MD|
|1:03pm – 1:08pm||Welcome & Goals FDA||Malvina Eydelman, MD|
Overview of MIGS Procedures
Co-Chairs: Marlene R. Moster, MD and Thomas W. Samuelson, MD
|1:08pm – 1:13pm||Leaving the Past Behind: Why We are Looking Forward to MIGS||Marlene R. Moster, MD|
|1:13pm – 1:20pm||Non-implantable MIGS Procedures||Brian A. Francis, MD|
|1:20pm – 1:27pm||Implantable MIGS Devices - Canal Based||ReayH. Brown, MD,|
|1:27pm – 1:34pm||Implantable MIGS Devices - Suprachoroidal Space||Steven D. Vold, MD|
|1:34pm – 1:41pm||Implantable MIGS Devices - Subconjunctival Space||Steven R. Sarkisian, Jr., MD|
|1:41pm – 1:53pm||FDA’s Regulation of Glaucoma devices||Tina Kiang, PhD|
|1:53pm – 2:05pm||ANSI Standard for Implantable Glaucoma Devices: A framework for clinical evaluation||Eva Rorer, MD|
|2:05pm – 2:10pm||Working Definition of MIGS and Panel Ground Rules||Thomas W. Samuelson, MD|
PANEL 1: Defining the Patient Population for Clinical Trials
Co-Chairs: David S. Friedman, MD and Richard A. Lewis, MD
|2:10pm – 2:17pm ||How to Classify Disease Severity in Clinical Trials of New Glaucoma Surgical Procedures||Rohit Varma, MD, MPH|
|2:17pm – 2:24pm||Severity Cutoff for Study inclusion and Associated Clinical Correlates||Henry D. Jampel, MD, MHS|
|2:24pm – 3:20pm||PANEL DISCUSSION||Henry D. Jampel, MD, MHS, Donald L. Budenz, MD, MPH, Husam Ansari, MD, PhD, Rohit Varma, MD, MPH, Brian E. Flowers, MD|
|3:20pm – 3:40pm||BREAK|
PANEL 2: Safety Endpoints & Adverse Outcomes
Co-chairs: Richard K. Parrish II, MD and Jeffrey M. Liebmann, MD
|3:40pm – 3:47pm||Hypotony As An Adverse Outcome of MIGS||Gregory L. Skuta, MD|
|3:47pm – 3:54pm||Substantial Increase in IOP Versus Baseline||Douglas J. Rhee, MD|
|3:54pm – 4:02pm||Substantial Visual Field Loss||Leon W. Herndon, Jr., MD|
|4:02pm – 4:50pm||PANEL DISCUSSION||George L. Spaeth, MD, Dale K. Heuer, MD, Cynthia G. Mattox, MD, James D. Brandt, MD, Gregory L. Skuta, MD|
PANEL 3: Effectiveness Endpoints
Co-chairs: Joseph A. Caprioli, MD and Ronald Leigh Fellman, MD
|4:50pm – 5:00pm||The Anatomical and Physiologic Basis for Outflow Surgery Effectiveness: What Can We Expect?||Murray A. Johnstone, MD|
|5:00pm – 5:05pm||Selection of Effectiveness Endpoints and Targets: What Do We Need to Show?||Malik Y. Kahook, MD|
|5:05pm – 5:10pm||Composite Safety and Effectiveness Endpoints: Are They Necessary to Measure Device Trial Success?||L. Jay Katz, MD|
|5:10pm – 6:00pm||PANEL DISCUSSION||Thomas W. Samuelson, MD, Malik Y. Kahook, MD, Paul Harasymovycz,MD, FRCSC, Robert J. Noecker, MD, David L. Epstein, MD,|
|6:00pm – 6:02pm||Concluding Remarks: AGS||Kuldev Singh, MD, MPH|
|6:02pm – 6:04pm||Concluding Remarks: FDA||Malvina B. Eydelman, MD|
Registration is $150 for AGS members, $300 for non-members and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online. The deadline for registration is February 10, 2014 at 5:00 p.m. EST. On-site registration will be available on the day of the public workshop. Early registration is recommended because facilities are limited. To register for the public workshop, please visit the American Glaucoma Society (AGS) website: http://www.americanglaucomasociety.net/professionals/events/
Those interested in attending but are unable to access the electronic registration site should contact AGS Customer Service to register 415-561-8587 or 866-561-8558 (toll free). Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone number. If there are any questions with registration, please contact the AGS administrative offices at 415-561-8587 or email to the attention of Amber Mendez (email@example.com). Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list.
If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communications and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5661, FAX: 301-847-8142, firstname.lastname@example.org.
For questions regarding workshop content please contact Dr. Michelle Tarver, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 2504, Silver Spring, MD 20993-0002, 301-796-5620, email: email@example.com.