Medical Devices

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.


Date, Time and Location

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.

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Webcast

This workshop will not be available by Webcast.

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Agenda

Time

Title

Speaker/Panelists

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

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Presentation

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Registration to Attend the Workshop

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 (ags@aao.org). Registrants will receive confirmation after they have been accepted.  You will be notified if you are on a waiting list.

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Contact Us

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, susan.monahan@fda.hhs.gov.

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: michelle.tarver@fda.hhs.gov.

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Page Last Updated: 07/11/2014
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